HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE— 510(k) K963160

Name: FDA 510(k) clearance K963160
Creator: U.S. Food and Drug Administration
Published: 1997-06-27

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K963160 for HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, Substantially Equivalent on 1997-06-27. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 1996-08-14
Decision date: 1997-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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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.