Data / Medical devices / Germany / Med Contact GMBH

Med Contact GMBH: FDA-registered device maker in Burladingen-Salmendingen Baden-Wurttemberg, Germany, 8 510(k) clearances

Name: Med Contact GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Med Contact GMBH is registered with the FDA (registration 3012460907) in Burladingen-Salmendingen Baden-Wurttemberg, Germany. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 19, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012460907
Address: Kornbuehlstrasse, Burladingen-Salmendingen Baden-Wurttemberg, Germany, 72393
Owner or operator: Med Contact GmbH (10050456)
Roles: Specification developer
First device listed: November 19, 2015
Registered through: 2026
Brand names listed: HF-cables (reusable)

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Electrosurgical, Active, Urological	FAS	2	Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Specification developer	accessdata.fda.gov
Endoscope, Ac-Powered And Accessories	GCP	2	Specification developer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Specification developer	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Specification developer	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
January 19, 2023	K221522	HF-cables (resusable)	GEI	Substantially Equivalent	Olympus Winter & Ibe GmbH	accessdata.fda.gov
June 20, 2012	K120418	ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES	FAS	Substantially Equivalent	Olympus Winter & Ibe GmbH	accessdata.fda.gov
July 1, 2010	K100275	WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS	FAS	Substantially Equivalent	Olympus Winter & Ibe GmbH	accessdata.fda.gov
March 17, 2008	K073450	SUTTER ELECTROSURGICAL CABLES	GEI	Substantially Equivalent	Sutter Medizintechnik GmbH	accessdata.fda.gov
February 24, 1999	K984417	BIPOLAR GRASPING FORCEPS BIQ+	GEI	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
September 15, 1995	K944200	HI-Q HAND INSTRUMENTS, OB/GYN USE	HET	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
November 29, 1994	K944201	HI-Q HAND INSTRUMENTS- UROLOGY	GCJ	Substantially Equivalent	Olympus America, Inc.	accessdata.fda.gov
April 2, 1979	K790071	ENDOSCOPE AND ACCESSORIES	GCP	Substantially Equivalent	Olympus Corp.	accessdata.fda.gov

Compare with other makers

Updated January 19, 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.