DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998— 510(k) K091355

Name: FDA 510(k) clearance K091355
Creator: U.S. Food and Drug Administration
Published: 2009-07-22

Substantially Equivalent

Conmed Endoscopic Technologies, Inc.

FDA 510(k) clearance K091355 for DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998, Substantially Equivalent on 2009-07-22. Applicant: Conmed Endoscopic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Conmed Endoscopic Technologies, Inc.
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2009-05-08
Decision date: 2009-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.