510(k) Report

FDA applicant

Era Endoscopy S.R.L.

Peccioli, IT1 decision2020–20200 recalls

FDA records 1 decision for Era Endoscopy S.R.L. (Peccioli, IT) in 2020: 1 510(k) clearance. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 3 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, gastroenterology and urology panel, where it files most

How often FDA has decided Era Endoscopy S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Era Endoscopy S.R.L. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Era Endoscopy S.R.L.’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?

  • FDFColonoscope And Accessories, Flexible/Rigid1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K190669EndoticsEra Endoscopy S.R.L. · 2020

The one decision as Era Endoscopy S.R.L. →