510(k) Report

FDA applicant

United States Endoscopy Group, Inc. (Us Endoscopy)

Mentor, OH1 decision2018–20180 recalls

FDA records 1 decision for United States Endoscopy Group, Inc. (Us Endoscopy) (Mentor, OH) in 2018: 1 510(k) clearance. All are in product code ODG (Endoscopic Ultrasound System…). 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 States Endoscopy Group, Inc. (Us Endoscopy)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — United States Endoscopy Group, Inc. (Us Endoscopy) by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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