510(k) Report

FDA applicant

United State Endoscopy Group, Inc.

Mentor, OH1 decision2017–20170 recalls

FDA records 1 decision for United State Endoscopy Group, Inc. (Mentor, OH) in 2017: 1 510(k) clearance. All are in product code FEQ (Pump, Air, Non-Manual, For Endoscope). 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 United State Endoscopy Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — United State Endoscopy Group, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FEQPump, Air, Non-Manual, For Endoscope1decision

What has FDA decided for it lately?

  • K163424AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINONUnited State Endoscopy Group, Inc. · 2017

The one decision as United State Endoscopy Group, Inc. →