Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip— 510(k) K183590

Substantially Equivalent

Olympus Medical Systems Corp.

FDA 510(k) clearance K183590 for Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip, Substantially Equivalent on 2019-08-01. Applicant: Olympus Medical Systems Corp..

Clearance details

Applicant: Olympus Medical Systems Corp.
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-21
Decision date: 2019-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hachioji-Shi, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.