SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP— 510(k) K141991

Substantially Equivalent

Olympus Medical Systems Copr.

FDA 510(k) clearance K141991 for SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP, Substantially Equivalent on 2015-03-31. Applicant: Olympus Medical Systems Copr..

Clearance details

Applicant: Olympus Medical Systems Copr.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2014-07-22
Decision date: 2015-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.