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Data / Medical devices / Germany / Guenter Bissinger Medizintechnik GMBH

Guenter Bissinger Medizintechnik GMBH: FDA-registered device maker in TENINGEN Baden-Wurttemberg, Germany, 10 510(k) clearances

Guenter Bissinger Medizintechnik GMBH is registered with the FDA (registration 8010456) in TENINGEN Baden-Wurttemberg, Germany. It lists 15 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 17, 2022. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Guenter Bissinger Medizintechnik GMBH
FDA registration number
8010456
FEI number
3002477156
Address
Hans-Theisen-Str. 1, TENINGEN Baden-Wurttemberg, Germany, 79331
Owner or operator
GUENTER BISSINGER MEDIZINTECHNIK GMBH (8010456)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
September 10, 1979
Registered through
2027
Brand names listed
FROELICH Suction Tube, SUPRA Non-Stick Bipolar Forceps

Devices it lists

DeviceProduct codeClassRoleSource
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)KNF2Contract manufactureraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufacturer, Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Contract manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Contract manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Contract manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufactureraccessdata.fda.gov
Instrument, MicrosurgicalGZX1Contract manufacturer, Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufacturer, Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Contract manufactureraccessdata.fda.gov
System, Surgical, Computer Controlled InstrumentNAY2Contract manufactureraccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Contract manufacturer, Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 17, 2022K213042Supra Non-Stick Bipolar ForcepsGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
April 5, 2018K172368Bipolar Micro-Coagulation ForcepsGEISubstantially EquivalentGunter Bissinger Medizintechnik GmbHaccessdata.fda.gov
March 12, 2015K143662Bissinger Monopolar Forceps and CablesGEISubstantially EquivalentMedagent, Inc.accessdata.fda.gov
February 20, 2015K150024Bissinger Monopolar CablesGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
July 29, 2005K051429CLARIS NON-STICK BIPOLAR FORCEPSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
October 27, 2004K042077BITECH BIPOLAR SCISSORSGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
March 11, 2004K033177POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXXHETSubstantially EquivalentGunter Bissinger Medizintechnik GmbHaccessdata.fda.gov
August 6, 1998K981919BISSINGER CABLES, CAT. NO. 801000XXGEISubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
May 21, 1998K970968BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPSHETSubstantially EquivalentGuenter Bissinger Medizintechnik GmbHaccessdata.fda.gov
October 8, 1996K963499MIRROR FINISH BIPOLAR FORCEPSGEISubstantially EquivalentJohnson & Johnson Professionals, Inc.accessdata.fda.gov

Compare with other makers

Updated November 17, 2022. 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.