Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2916714

FEI Number

2916714

Entity Name

AESCULAP, INC.

City/State/Country

CENTER VALLEY, PA, US

Establishment Address

3773 CORPORATE PKWY., CENTER VALLEY, PA 18034, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

AESCULAP, INC. (Owner Number: 2916714)

Owner / Operator Contact Address

3773 CORPORATE PKWY., --, Center Valley, PA 18034, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aesculap Aesculap Aesculap Aesculap Aesculap RETRACTOR RICHARDSON APPENDS Aesculap MANUAL OPERATING TABLE CHAIR AND ACCESSORIES Aesculap Aesculap Aesculap Aesculap AESCULAP GRASPER DENTAL HAND INSTRUMENT Aesculap Aesculap Aesculap FORCEPS ENT EAR NOSE AND THROAT Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap ORTHOPEDIC TTACHMENT ,AC-POWERED MOTOR AND ACCESSORY Aesculap Aesculap SURGICAL CAMERA AND ACCESSORIES Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap KERRISON RONGEUR CARVABLE SILICON BLOCK Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap VARIOIUS DENTAL RETRACTOR ACCESSORIES Aesculap aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap SUCTION UNIT ATTACHMENTS HMENTS SURGICAL INSTRUMENT MOTORS AND ACCE Aesculap VACUUM-POWERED BODY F Aesculap Aesculap aesculap DENTAL INSTRUMENT Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap BONE HOOK Aesculap PROSPACE BONE ALIF Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap STERNUM SAW BLADE AESCULAP Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Prestige Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap OBSTETRIC-GYNECOLOGIC SPE Aesculap Aesculap PRESSURE INFUSOR FOR AN I.V. BAG DENTAL INSTRUMENT Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap FORCEPS Aesculap Aesculap Aesculap OSTEOTOME Aesculap AESCULAP Aesculap ATTACHMENT SURGICAL INSTRUMENT MOTORS AND ACCE CHMENT Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap RETRACTOR Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap Aesculap ARTHROSCOPIC ACCESSORIES Aesculap SURGICAL CAMERA AND ACCESSORIES Aesculap SINOSCOPY TROCAR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2015-02-10
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2004-12-03
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2017-11-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-05-02
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2008-07-10
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2018-09-18
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-09-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-30
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HCI	Applier, Aneurysm Clip	Neurology	Class 2	882.4175	2017-11-28
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2008-07-07
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2015-10-23
DSS	Clip, Vascular	Cardiovascular	Class 2	870.3250	2015-10-23
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2015-10-23
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2016-06-16
HBO	Clip, Scalp	Neurology	Class 2	882.4150	2016-06-16
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2004-12-02
GBY	Catheter, Eustachian, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2008-07-08
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2007-12-21
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2004-11-08
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2008-07-08
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	1990-03-21
HWI	Corkscrew	Orthopedic	Class 1	888.4540	2008-07-10
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2001-01-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1996-12-30
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2008-02-27
EKB	Explorer, Operative	Dental	Class 1	872.4565	2004-11-12
HCI	Applier, Aneurysm Clip	Neurology	Class 2	882.4175	2018-04-17
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2005-10-26
HYA	Forceps, Wire Holding	General, Plastic Surgery	Class 1	878.4800	2008-07-08
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2018-05-30
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2015-02-13
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2009-11-10
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-12-11
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-09-17
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2019-12-17
JOF	Polymer, Ent Synthetic, Porous Polyethylene	Ear, Nose, Throat	Class 2	874.3620	2019-12-17
HBM	Headrest, Neurosurgical	Neurology	Class 1	882.4440	2018-09-19
EZM	Dilator, Esophageal (Metal Olive) Gastro-Urology	Gastroenterology, Urology	Class 2	876.5365	2008-07-08
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2018-10-26
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-01-14
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2001-12-07
FFR	Device, Locking, For Intestinal Clamp	Gastroenterology, Urology	Class 1	876.4730	2001-10-12
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2016-08-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2012-01-04
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2018-09-19
JYE	Chisel, Middle-Ear	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2006-05-22
KCA	Tonsillectome	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2008-07-10
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-10-22
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2008-02-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2003-11-25
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	1990-03-21
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2008-07-08
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2003-11-25
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2015-08-25
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-08-28
HER	Pelvimeter, External	Obstetrics/Gynecology	Class 1	884.4520	2008-07-10
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2007-12-06
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2001-10-16
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Gastroenterology, Urology	Class 1	876.5090	2008-07-08
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-05-22
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	Class 1	876.4730	1990-02-05
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2001-10-12
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2015-07-28
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2012-06-22
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2015-03-04
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-02-05
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2022-07-06
HXC	Wrench	Orthopedic	Class 1	888.4540	2008-01-16
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	1990-03-21
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2008-02-05
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-07-27
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2014-07-09
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-01-24
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1990-03-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-05-10
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2008-07-08
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	1990-03-21
NNR	Block, Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2005-02-18
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2004-09-03
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2001-10-09
JEY	Plate, Bone	Dental	Class 2	872.4760	2008-06-02
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2019-02-06
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2019-02-06
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2019-02-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2001-09-24
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2020-02-04
GRX	Antisera, All Leptospira Spp.	Microbiology	Class 2	866.3350	2020-02-04
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2020-02-04
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-05-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-07-18
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-03-11
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2012-11-15
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2006-09-12
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2001-10-09
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2001-12-10
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2003-08-13
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-12-16
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-12-11
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-12-11
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2018-03-06
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-03-09
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2007-12-21
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2008-07-08
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	Class 1	878.4950	2008-07-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2007-12-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-06
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2008-07-10
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2004-07-15
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2020-05-14
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2008-07-08
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2014-07-29
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2008-07-08
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2008-01-25
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2008-07-07
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2001-12-11
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1996-12-30
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2008-07-08
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2009-08-14
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2008-07-10
HCI	Applier, Aneurysm Clip	Neurology	Class 2	882.4175	2016-04-28
JYY	Rasp, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2024-12-18
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-07-27
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	2001-10-05
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2001-09-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2012-05-15
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2008-07-07
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2018-09-25
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2016-05-02
LXK	Scrapper, Skin Specimen	General, Plastic Surgery	Class 1	878.4800	2008-07-14
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2006-03-02
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2016-07-22
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2003-11-25
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-02-15
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2018-10-22
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	1990-03-20
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2019-07-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2016-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-05-10
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	1990-03-21
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
EIG	Retractor, All Types	Dental	Class 1	872.4565	2008-07-07
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2014-07-02
JEP	Retainer, Matrix	Dental	Class 1	872.4565	1990-03-21
HAD	Rongeur, Powered	Neurology	Class 2	882.4845	2008-07-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2011-05-04
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-01-14
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2007-12-06
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2018-04-02
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	2008-07-08
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2018-01-29
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-12-07
HCI	Applier, Aneurysm Clip	Neurology	Class 2	882.4175	2022-03-18
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2006-05-18
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-01-14
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2018-05-07
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2003-08-13
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2014-07-01
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-03-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-15
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2015-03-06
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2018-05-10
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2021-01-22
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2001-10-05
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2006-12-28
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
JYA	Scissors, Wire Cutting, Ent, Sterile	Ear, Nose, Throat	Class 1	874.3540	2008-07-08
HWW	Countersink	Orthopedic	Class 1	888.4540	2008-07-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-12-06
KTF	Punch, Ent	Ear, Nose, Throat	Class 1	874.4420	2005-02-01
HBQ	Instrument, Clip Removal	Neurology	Class 1	882.4200	2009-07-09
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	1990-03-21
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2008-07-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-02-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-07-05
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2014-02-28
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2006-06-16
KBH	Adenotome	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2012-11-27
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2012-11-27
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2015-04-02
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2001-10-09
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2001-12-11
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2012-07-09
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2015-02-25
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2015-03-06
DWH	Blade, Saw, Surgical, Cardiovascular	General, Plastic Surgery	Class 1	878.4820	2001-09-20
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2016-08-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-07-05
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-07-18
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2001-12-07
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2019-01-21
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2007-02-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-07-05
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2015-08-17
HWB	Extractor	Orthopedic	Class 1	888.4540	2001-12-11
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2015-03-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-19
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2016-06-28
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2015-05-22
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	2001-12-10
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-02-22
KCF	Dilator, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-02-25
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2001-10-12
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2016-07-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-04-11
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2008-07-10
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2018-04-13
HBW	Fastener, Plate, Cranioplasty	Neurology	Class 2	882.5360	2019-02-06
GWO	Plate, Cranioplasty, Preformed, Alterable	Neurology	Class 2	882.5320	2019-02-06
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2019-02-06
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2008-07-10
HCD	Cannula, Ventricular	Neurology	Class 1	882.4060	2008-07-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-07-29
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1990-03-21
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2001-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-22
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2012-12-05
HCI	Applier, Aneurysm Clip	Neurology	Class 2	882.4175	2012-12-05
HXB	Probe	Orthopedic	Class 1	888.4540	2001-12-11
EJY	Pliers, Operative	Dental	Class 1	872.4565	2001-10-05
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	1989-11-27
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2018-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-27
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2017-12-15
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2018-04-20
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2018-04-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-04-13
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2001-10-11
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2008-07-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2005-09-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-06-10
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2015-03-05
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2015-03-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2016-05-11
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2015-04-01
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2001-12-11
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2008-07-08
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2018-05-17
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	1990-03-21
KNA	Instrument, Manual, Specialized Obstetric-Gynecologic	Obstetrics/Gynecology	Class 2	884.4530	2003-11-25
HWJ	Awl	Orthopedic	Class 1	888.4540	2006-06-13
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2008-07-08
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2005-07-21
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2023-07-05
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2004-11-12
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2001-10-12
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2007-02-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-05-10
HWQ	Passer	Orthopedic	Class 1	888.4540	2007-02-15
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2008-07-10
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2006-06-05
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2007-12-06
HCI	Applier, Aneurysm Clip	Neurology	Class 2	882.4175	2008-01-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-06
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2001-12-10
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HWA	Impactor	Orthopedic	Class 1	888.4540	2003-11-25
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2018-05-18
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2006-08-10
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2008-02-05
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-04-26
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-03-21
HBO	Clip, Scalp	Neurology	Class 2	882.4150	2007-12-06
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2015-02-12
HXG	Tamp	Orthopedic	Class 1	888.4540	2016-03-16
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-01-14
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2008-07-08
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2008-07-10
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2004-03-25
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2002-07-30
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2007-12-06
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-02-05
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2008-07-07
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2006-03-02
HCH	Clip, Aneurysm	Neurology	Class 2	882.5200	2015-02-25
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-12-07
HTX	Rongeur	Orthopedic	Class 1	888.4540	2001-12-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2016-06-30
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2016-08-01
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2008-07-07
GET	Motor, Surgical Instrument, Pneumatic Powered	General, Plastic Surgery	Class 1	878.4820	2003-11-25
HTP	File	Orthopedic	Class 1	888.4540	2008-07-10
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2008-07-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2015-08-25
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2008-07-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-07-05
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2009-04-13
FZQ	Clip, Removable (Skin)	General, Plastic Surgery	Class 1	878.4320	1990-03-21
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-12-28
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2016-08-03
KBT	Punch, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-07-08
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2014-11-17
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2018-11-12
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2018-11-12
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	1990-03-21
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2008-07-08
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1989-11-27
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	1990-03-13
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2008-07-07
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2017-03-13
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2008-01-23
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2008-07-10
EIS	Remover, Crown	Dental	Class 1	872.4565	1990-03-21
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2013-08-08
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2001-10-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-05-10
FBQ	Trocar, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5090	2007-12-06
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2006-12-28
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-07-08
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2001-10-09
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2004-11-08
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2008-07-08
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2003-11-25
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-12-08

Official Correspondent

Kamaal Anas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AESCULAP, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003587896	AESCULAP, INC.	HAZELWOOD, MO, US

Related 510(k) Records

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K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2916714. Last updated year: 2026. Please use registration number 2916714 when referencing this establishment in official correspondence.