510(k) K130718— PEERSCOPE SYSTEM

Substantially Equivalent

Peermedical , Ltd.

Clearance details

Applicant: Peermedical , Ltd.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2013-03-18
Decision date: 2013-04-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.