510(k) Report

FDA applicant

Gimmi GmbH

Amsterdam, Nh, NL7 decisions2001–20261 recall

FDA records 7 decisions for Gimmi GmbH (Amsterdam, Nh, NL) from 2001 to 2026: 7 510(k) clearances. Most are in product codes HIH (Hysteroscope (And Accessories)) and GCT (Light Source, Endoscope, Xenon Arc). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 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 Gimmi GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009: 12010: 22026 (partial year): 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Gimmi 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?

  • HIHHysteroscope (And Accessories)2decisions
  • GCTLight Source, Endoscope, Xenon Arc1decision
  • FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology1decision
  • EOQBronchoscope (Flexible Or Rigid)1decision
  • HCHClip, Aneurysm1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K012660Gimmi'alpha' Endoscopes & AccessoriesGimmi GmbH · 20014cite it
  • K012869Gimmi Alpha Hysteroscopes & Accessories, Models E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25Gimmi GmbH · 20021cites it

What has FDA decided for it lately?

  • K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH · 2026
  • K092421Alphahysteroscope, Fiberoptic, Operative and DiagnosticGimmi GmbH · 2010
  • K093125Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010
  • K081640Gimmi Aneurysm Clips and Applying ForcepsGimmi GmbH · 2009
  • K012869Gimmi Alpha Hysteroscopes & Accessories, Models E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25Gimmi GmbH · 2002
  • K012660Gimmi'alpha' Endoscopes & AccessoriesGimmi GmbH · 20011 recall
  • K013731Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71; Gimmi Alpha Bronchoscopes Model #…Gimmi GmbH · 2001

All 7 as Gimmi GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K012660ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD…Dec 3, 2024Class II