510(k) Report

FDA applicant

Fetzer Medical GmbH & Co. KG

Tuttlingen, DE3 decisions2016–20184 recalls

FDA records 3 decisions for Fetzer Medical GmbH & Co. KG (Tuttlingen, DE) from 2016 to 2018: 3 510(k) clearances. Most are in product codes GZT (Retractor, Self-Retaining, For Neurosurgery) and DWP (Dilator, Vessel, Surgical). Its devices cite 5 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Fetzer Medical GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12017: 12018: 1
2016high 1 (2016) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

4in 2018

2018: 4
2016high 4 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Fetzer Medical GmbH & Co. KG by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fetzer Medical GmbH & Co. KG’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?

  • GZTRetractor, Self-Retaining, For Neurosurgery1decision
  • DWPDilator, Vessel, Surgical1decision
  • HCZForceps, Surgical, Gynecological1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K161004Self-retaining RetractorFetzer Medical GmbH & Co. KG · 20161cites it

What has FDA decided for it lately?

  • K172661Fetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KG · 20184 recalls
  • K163524Vessel DilatorFetzer Medical GmbH & Co. KG · 2017
  • K161004Self-retaining RetractorFetzer Medical GmbH & Co. KG · 2016

All 3 as Fetzer Medical GmbH & Co. KG →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K17266112002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product…Dec 28, 2018Class II
  • K17266116600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code…Dec 28, 2018Class II
  • K17266116600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code…Dec 28, 2018Class II
  • K17266112002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product…Dec 28, 2018Class II