J-VAC BULB SUCTION RESERVOIR— 510(k) K922895

Name: FDA 510(k) clearance K922895
Creator: U.S. Food and Drug Administration
Published: 1992-09-15

Substantially Equivalent

Johnson & Johnson Medical, Inc.

FDA 510(k) clearance K922895 for J-VAC BULB SUCTION RESERVOIR, Substantially Equivalent on 1992-09-15. Applicant: Johnson & Johnson Medical, Inc.. Device class: 1.

Clearance details

Applicant: Johnson & Johnson Medical, Inc.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1992-06-16
Decision date: 1992-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.