510(k) Report

FDA applicant

Gunter Bissinger Medizintechnik GmbH

Teningen, DE2 decisions2004–20180 recalls

FDA records 2 decisions for Gunter Bissinger Medizintechnik GmbH (Teningen, DE) from 2004 to 2018: 2 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Gunter Bissinger Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gunter Bissinger Medizintechnik GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • HETLaparoscope, Gynecologic (And Accessories)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 20182cite it
  • K033177Powergrip Bipolar Coagulation Forceps, Model 824XXXXXGunter Bissinger Medizintechnik GmbH · 20041cites it

What has FDA decided for it lately?

  • K172368Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH · 2018
  • K033177Powergrip Bipolar Coagulation Forceps, Model 824XXXXXGunter Bissinger Medizintechnik GmbH · 2004

All 2 as Gunter Bissinger Medizintechnik GmbH →