Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611278

FEI Number

3002808264

Entity Name

Stengelin Medical GmbH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

AM KIRCHENWEG 5, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Stengelin Medical (Owner Number: 8010373)

Owner / Operator Contact Address

AM KIRCHENWEG 5, --, 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

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2022-11-17
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2013-01-10
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-10
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	1989-04-03
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2012-11-30
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-01-09
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1984-01-30
HWQ	Passer	Orthopedic	Class 1	888.4540	2016-12-13
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2013-07-05
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2013-01-15
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2013-01-10
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2013-01-10
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	1984-01-30
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	2013-01-10
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1984-01-30
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2013-01-10
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2012-12-03
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-10
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2012-12-03
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-09
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-01-10
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1984-01-30
HTP	File	Orthopedic	Class 1	888.4540	2012-12-03
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2013-01-10
KAQ	Gouge, Nasal, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-10
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-01-11
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2013-02-28
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-02-28
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1983-09-27
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2013-02-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2009-07-15
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1984-01-30
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2013-01-09
KBC	Saw, Nasal	Ear, Nose, Throat	Class 1	874.4420	2013-01-10
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2013-02-28
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2013-01-15
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-10
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	1983-09-27
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2012-11-30
JYD	Chisel, Mastoid	General, Plastic Surgery	Class 1	878.4800	2013-01-10
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2008-12-18
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1979-05-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-10-28
EIG	Retractor, All Types	Dental	Class 1	872.4565	1984-01-30
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2017-05-19
GWY	Pinwheel	Neurology	Class 1	882.1750	2012-11-30
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2013-01-11
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2013-07-15
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2013-01-15
HWJ	Awl	Orthopedic	Class 1	888.4540	2001-03-20
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-10
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-01-15
HWO	Skid, Bone	Orthopedic	Class 1	888.4540	2013-01-10
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2013-01-10
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-07-05
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2013-01-10
HWB	Extractor	Orthopedic	Class 1	888.4540	2001-03-20

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

Stengelin Medical

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
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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611278. Last updated year: 2026. Please use registration number 9611278 when referencing this establishment in official correspondence.