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FEHLING INSTRUMENTS GmbH: FDA-registered device maker in KARLSTEIN Bavaria, Germany, 3 510(k) clearances

Name: FEHLING INSTRUMENTS GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

FEHLING INSTRUMENTS GmbH is registered with the FDA (registration 9615005) in KARLSTEIN Bavaria, Germany. It lists 21 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 20, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9615005
FEI number: 3001286223
Address: Seligenstaedter Str. 100, KARLSTEIN Bavaria, Germany, 63791
Owner or operator: FEHLING INSTRUMENTS GmbH (9004104)
Roles: Complaint file establishment, Contract sterilizer, Exporter to the US, Manufacturer, Specification developer
First device listed: May 14, 1998
Registered through: 2026
Brand names listed: FORCEPS, Fehling Biopsy Forceps, MICS MV Superflex Atrial Retractor, Probe, RONGEUR, SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe, Surgical Cannula, chisel and more

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Surgical, General & Plastic Surgery	GEA	1	Complaint file establishment, Exporter to the US, Specification developer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Device, Biopsy, Endomyocardial	DWZ	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Dilator, Vessel, Surgical	DWP	2	Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Contract sterilizer, Manufacturer	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Probe, Ent	KAK	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Manufacturer	accessdata.fda.gov
Rongeur, Manual	HAE	2	Manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Sizer, Heart-Valve, Prosthesis	DTI	1	Manufacturer	accessdata.fda.gov
Spatula, Surgical, General & Plastic Surgery	GAF	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 20, 2023	K220981	SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe	DWP	Substantially Equivalent	Fehling Surgical Instruments, Inc.	accessdata.fda.gov
June 2, 2017	K170726	Biopsy Forceps	DWZ	Substantially Equivalent	Fehling Instruments GmbH & Co. KG	accessdata.fda.gov
August 4, 2016	K153243	Fehling-Punches	HAE	Substantially Equivalent	Fehling Instruments GmbH & Co. KG	accessdata.fda.gov

Compare with other makers

Updated April 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.