510(k) Report

FDA applicant

Scholly Fiberoptic GmbH

Denzlingen, DE3 decisions1999–20140 recalls

FDA records 3 decisions for Scholly Fiberoptic GmbH (Denzlingen, DE) from 1999 to 2014: 3 510(k) clearances. Most are in product codes HRX (Arthroscope) and EIA (Unit, Operative Dental). 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, orthopedic panel, where it files most

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

FDA decisions per year

2in 2014

2014: 2
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scholly Fiberoptic 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?

  • HRXArthroscope1decision
  • EIAUnit, Operative Dental1decision
  • EOQBronchoscope (Flexible Or Rigid)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 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.

  • K141366Video Bronchoscope SystemScholly Fiberoptic GmbH · 20141cites it

What has FDA decided for it lately?

  • K141366Video Bronchoscope SystemScholly Fiberoptic GmbH · 2014
  • K133682Schoelly ArthroscopeScholly Fiberoptic GmbH · 2014
  • K984556Scican ClassicScholly Fiberoptic GmbH · 1999

All 3 as Scholly Fiberoptic GmbH →