Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044098

FEI Number

3004028763

Entity Name

HGR INSTRUMENTE GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

Sattlerstrasse 35, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HGR INSTRUMENTE GMBH (Owner Number: 9067456)

Owner / Operator Contact Address

Sattlerstrasse 35, --, TUTTLINGEN, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GROSSMAN FACIAL ELEV 6-3/4 Ball Probe medium Ball Probe large

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	1999-12-20
MZY	Graft, Vascular, Stainless Steel Tunneler	Cardiovascular	Class 2	870.3450	2013-01-18
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-07-04
HTP	File	Orthopedic	Class 1	888.4540	2008-07-25
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-12-20
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2012-11-29
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1999-12-20
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2005-11-09
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2013-07-25
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2018-01-22
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-12-20
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2025-07-31
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-12-20
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-12-19
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1999-12-20
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2009-04-20
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2008-12-19
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2010-02-01
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2000-02-04
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-01-22
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-02-14
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-01-13
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-12-20
FAH	Dilator, Urethral, Mechanical	Gastroenterology, Urology	Class 2	876.5520	2025-02-14
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2025-02-14
FAX	Bougie, Urological	Gastroenterology, Urology	Class 1	876.5520	2025-02-14
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2025-02-14
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2012-12-04
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	1992-12-08
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2013-06-25
GEO	File, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-09-26
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2012-11-13
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-01-13
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2012-12-04
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2018-01-22
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2018-01-22
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-03-18
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2008-11-14
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2009-02-05
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-12-20
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2014-02-26
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2020-06-04
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2014-04-14
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-02-20
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2010-02-02
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2019-02-06
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2013-01-21
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-02-18
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2012-12-04
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	1999-12-20
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2013-01-30
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2016-07-04
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2008-11-14
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2002-05-30
HWA	Impactor	Orthopedic	Class 1	888.4540	2009-09-17
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2018-01-22
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	1999-12-20
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-02-28
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-04-09
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2012-09-23
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2011-12-22
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2023-07-27
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-12-04
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2020-04-01
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	1992-12-08
JYQ	Loop, Wire	Ear, Nose, Throat	Class 1	874.4420	2020-12-04
HWQ	Passer	Orthopedic	Class 1	888.4540	2020-04-01
HTO	Reamer	Orthopedic	Class 1	888.4540	2019-06-11
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	1999-12-20
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2018-02-19
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	1999-12-20
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-03-06
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2012-12-04
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2016-11-02
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2013-08-28
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2008-11-14
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1999-12-20
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1999-12-20
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-25
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-07-25
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2024-02-20
HXB	Probe	Orthopedic	Class 1	888.4540	2012-04-19
HWW	Countersink	Orthopedic	Class 1	888.4540	2014-07-08
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2012-09-13
KBQ	Knife, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2019-10-25
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2000-01-13
JYE	Chisel, Middle-Ear	Ear, Nose, Throat	Class 1	874.4420	2018-01-22
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-12-20
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2020-07-08

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

HGR INSTRUMENTE GMBH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number	Establishment Name	Location
9610612	AESCULAP AG	TUTTLINGEN, DONAU Baden-Wurttemberg, DE
3003244954	ZEPF MEDICAL INSTRUMENTS GMBH	SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE
3021680161	BEAR-ENT, LLC	Malvern, PA, US
9613926	Gesco Healthcare Private Limited	CHENNAI, Tamil Nadu, IN
3016965929	COMFORT SURGICAL INSTRUMENTS	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044098. Last updated year: 2026. Please use registration number 8044098 when referencing this establishment in official correspondence.