STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU— 510(k) K914694

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K914694 for STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU, Substantially Equivalent on 1992-01-16. Applicant: Depuy, Inc..

Clearance details

Applicant: Depuy, Inc.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 1991-10-18
Decision date: 1992-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.