Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615005

FEI Number

3001286223

Entity Name

FEHLING INSTRUMENTS GmbH

City/State/Country

KARLSTEIN Bavaria, DE

Establishment Address

Seligenstaedter Str. 100, KARLSTEIN Bavaria 63791, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FEHLING INSTRUMENTS GmbH (Owner Number: 9004104)

Owner / Operator Contact Address

Seligenstaedter Str. 100, Karlstein, DE-BY 63791, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

knot tying inst. SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe tray microsurgical inst MICS MV Superflex Atrial Retractor surgical inst chisel RONGEUR Probe Fehling Biopsy Forceps retractor surgical instrument scissors screw driver Surgical Cannula manual rongeur FORCEPS sizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2012-07-24
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2024-07-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-07-19
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2012-07-19
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1998-05-14
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1998-05-15
HTX	Rongeur	Orthopedic	Class 1	888.4540	1998-05-15
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-07-19
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2017-06-08
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2012-07-19
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2012-07-19
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-07-19
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-07-24
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-07-31
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2016-08-10
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-05-15
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	Class 1	870.3945	2012-07-24

Official Correspondent

No official correspondent registered.

US Agent Details

Hayden Hosch Email: hayden@fehlingsurgical.com Phone: (800) 3345464

Related Public Records

Same Entity

FEHLING INSTRUMENTS 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
K810894	American Edwards Laboratories	FOGARTY FLEXIBLE CALIBRATOR	1981-05-15
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
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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8020712	LOCKDOWN MEDICAL LIMITED	Redditch Worcestershire, GB
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
2953359	Sterigenics U.S. LLC	Hayward, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615005. Last updated year: 2026. Please use registration number 9615005 when referencing this establishment in official correspondence.