510(k) Report

FDA applicant

Hans Hermann GmbH

Wurmlingen, DE2 decisions1998–20050 recalls

FDA records 2 decisions for Hans Hermann GmbH (Wurmlingen, DE) from 1998 to 2005: 2 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and JEY (Plate, Bone). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Hans Hermann GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hans Hermann GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • JEYPlate, Bone1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K051610Hans Hermann Laparoscopes and AccessoriesHans Hermann GmbH · 20054cite it

What has FDA decided for it lately?

  • K051610Hans Hermann Laparoscopes and AccessoriesHans Hermann GmbH · 2005
  • K983535The Titanium Miniplating System, the Titanium Microplating System, the Titanium Mediumplating System, Model…Hans Hermann GmbH · 1998

All 2 as Hans Hermann GmbH →

Other applicant names beginning “Hans”

FDA records each applicant name separately; these may or may not be the same firm.

Hans Rudolph, Inc. 11Hans Biomed Corporation 9Hans J. Brouwers & Assoc. 2Hans-Juergen Huchel 1Hans Gevder 1