510(k) Report

FDA applicant

Guenter Bissinger Medizintechnik GmbH

Teningen, DE6 decisions1998–20220 recalls

FDA records 6 decisions for Guenter Bissinger Medizintechnik GmbH (Teningen, DE) from 1998 to 2022: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 6 predicates, 1 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 Guenter Bissinger Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015: 12022: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Guenter Bissinger Medizintechnik GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions
  • HETLaparoscope, Gynecologic (And Accessories)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 1 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.

  • K051429Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 20058cite it
  • K042077Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 20043cite it
  • K970968Bissinger Detachable Bipolar Coagulation-ForcepsGuenter Bissinger Medizintechnik GmbH · 19982cite it
  • K981919Bissinger Cables, Cat. NO. 801000XXGuenter Bissinger Medizintechnik GmbH · 19981cites it

What has FDA decided for it lately?

  • K213042Supra Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2022
  • K150024Bissinger Monopolar CablesGuenter Bissinger Medizintechnik GmbH · 2015
  • K051429Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
  • K042077Bitech Bipolar ScissorsGuenter Bissinger Medizintechnik GmbH · 2004
  • K981919Bissinger Cables, Cat. NO. 801000XXGuenter Bissinger Medizintechnik GmbH · 1998
  • K970968Bissinger Detachable Bipolar Coagulation-ForcepsGuenter Bissinger Medizintechnik GmbH · 1998

All 6 as Guenter Bissinger Medizintechnik GmbH →