Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005528784

FEI Number

3005528784

Entity Name

Ambler Surgical, LLC

City/State/Country

EXTON, PA, US

Establishment Address

436 Creamery Way Ste 300, EXTON, PA 19341, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

AMBLER SURGICAL, LLC (Owner Number: 9106120)

Owner / Operator Contact Address

436 Creamery Way Ste 300, Exton, PA 19341, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ambler Ambler Ambler Ambler Ambler Honan Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Ambler Surgical Ambler Ambler Ambler Ambler Ambler Ambler

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNS	Expressor	Ophthalmic	Class 1	886.4350	2016-06-09
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	2016-06-08
JZD	Snare, Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2016-06-08
KBB	Rongeur, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
LCC	Applicator, Ocular Pressure	Ophthalmic	Class 2	886.4610	2016-06-15
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2016-06-09
NNU	Scissors, Wire Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2016-06-15
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-10
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2016-06-08
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2020-12-29
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
FXE	Speculum, Non-Illuminated	General, Plastic Surgery	Class 1	878.1800	2016-06-08
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HWQ	Passer	Orthopedic	Class 1	888.4540	2016-06-09
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-06-09
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2016-06-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-16
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2016-06-17
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2013-01-24
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2016-06-09
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2016-06-09
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2016-06-09
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2016-06-08
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2016-06-09
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-16
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2016-06-16
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2016-06-09
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-10
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2016-06-08
JZY	Knife, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2016-06-09
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2016-06-09
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2016-06-08
EYR	Tourniquet, Gastro-Urology	General, Plastic Surgery	Class 1	878.5900	2016-06-08
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2016-06-08
KCE	Cannulae, Bronchial	General, Plastic Surgery	Class 1	878.4800	2016-06-10
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-12-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-12-29
HDE	Hook, Fibroid, Gynecological	Obstetrics/Gynecology	Class 1	884.4520	2016-06-09
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
FBS	Sound, Metal, Interconnected	Gastroenterology, Urology	Class 1	876.4590	2016-06-08
HTP	File	Orthopedic	Class 1	888.4540	2016-06-09
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2016-06-09
HOD	Clamp, Eyelid, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
EIG	Retractor, All Types	Dental	Class 1	872.4565	2016-06-08
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2016-06-10
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2016-06-08
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2016-06-16
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2016-06-09
JYD	Chisel, Mastoid	General, Plastic Surgery	Class 1	878.4800	2016-06-09
HDK	Scissors, Episiotomy	Obstetrics/Gynecology	Class 1	884.4520	2016-06-09
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-16
KAO	Curette, Ethmoid	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HOB	Clamp, Muscle, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2020-12-29
FFN	Clamp, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2016-06-08
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-06-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-16
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HNE	Snare, Enucleating	Ophthalmic	Class 1	886.4350	2016-06-09
JYF	Clamp, Ossicle Holding	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2016-06-09
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2016-06-08
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2016-06-08
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-06-10
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-09
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2016-06-16
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2016-06-08
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2016-06-10
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2016-06-08
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2020-12-29
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2016-06-09
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2016-06-08
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2016-06-08
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2016-06-09
KAJ	Mobilizer, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2016-06-16
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	Class 1	886.4070	2016-06-10
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-08
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2016-06-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-16
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-21
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2016-06-08
HWI	Corkscrew	Orthopedic	Class 1	888.4540	2016-06-09
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2016-06-09
FXG	Specula Accessories	General, Plastic Surgery	Class 1	878.1800	2016-06-08
KTZ	Caliper	Orthopedic	Class 1	888.4150	2016-06-10
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2020-12-29
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2016-06-10
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2016-06-16
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2016-06-08
HXC	Wrench	Orthopedic	Class 1	888.4540	2016-06-09
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2016-06-15
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2016-06-15
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2020-12-29
KAQ	Gouge, Nasal, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-08
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2016-06-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-06-16
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2016-06-09
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2016-06-08
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	Class 1	876.4730	2020-12-29
HNJ	Punch, Corneo-Scleral	Ophthalmic	Class 1	886.4350	2016-06-09
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2016-06-08
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
HWW	Countersink	Orthopedic	Class 1	888.4540	2020-12-29
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2016-06-08
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2016-06-10
HXB	Probe	Orthopedic	Class 1	888.4540	2016-06-09
HWJ	Awl	Orthopedic	Class 1	888.4540	2016-06-09
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-13
NNN	Crimper, Wire, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2016-06-10
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
JYZ	Rod, Measuring Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
KBH	Adenotome	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2020-12-29
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-12-29
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2016-06-17
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2016-06-09
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2016-06-10
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-06-10
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-08
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-06-08
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2016-06-10
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2020-12-29
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-15
KBP	Hook, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2016-06-08
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2016-09-14
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
HXG	Tamp	Orthopedic	Class 1	888.4540	2016-06-09
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2016-06-09
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-21
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2016-06-09
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2016-06-16
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-08-21
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
JYY	Rasp, Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2016-06-08
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2016-06-09
HTX	Rongeur	Orthopedic	Class 1	888.4540	2016-06-09
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
KBE	Snare, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HGC	Clamp, Uterine	Obstetrics/Gynecology	Class 1	884.4520	2020-12-29
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2016-06-10
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2016-06-09
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-06-15
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2016-06-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-06-17
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2016-06-09
HCD	Cannula, Ventricular	Neurology	Class 1	882.4060	2020-12-29
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-08
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2016-06-09
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2016-06-08
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-24
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-06-09
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2016-06-09

Official Correspondent

MARTIN ANTHONY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMBLER SURGICAL, LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005528784. Last updated year: 2026. Please use registration number 3005528784 when referencing this establishment in official correspondence.