HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS— 510(k) K990687

Substantially Equivalent

Olympus Optical, Co.

FDA 510(k) clearance K990687 for HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS, Substantially Equivalent on 1999-03-26. Applicant: Olympus Optical, Co..

Clearance details

Applicant: Olympus Optical, Co.
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 1999-03-01
Decision date: 1999-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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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.