PENN 3-RING HANDLE— 510(k) K862729

Substantially Equivalent

Penn Medical Devices, Inc.

FDA 510(k) clearance K862729 for PENN 3-RING HANDLE, Substantially Equivalent on 1986-10-24. Applicant: Penn Medical Devices, Inc..

Clearance details

Applicant: Penn Medical Devices, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1986-07-18
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basking Ridge, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.