Anchor Tissue Retrieval System by CONMED— 510(k) K173822

Name: FDA 510(k) clearance K173822
Creator: U.S. Food and Drug Administration
Published: 2018-09-11

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K173822 for Anchor Tissue Retrieval System by CONMED, Substantially Equivalent on 2018-09-11. Applicant: Conmed Corporation. Device class: 2.

Clearance details

Applicant: Conmed Corporation
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2017-12-18
Decision date: 2018-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.