ROTH NET RETRIEVER— 510(k) K122462

Substantially Equivalent

United States Endoscopy Group, Inc.

FDA 510(k) clearance K122462 for ROTH NET RETRIEVER, Substantially Equivalent on 2012-09-11. Applicant: United States Endoscopy Group, Inc..

Clearance details

Applicant: United States Endoscopy Group, Inc.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 2012-08-13
Decision date: 2012-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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.