HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS— 510(k) K880650

Name: FDA 510(k) clearance K880650
Creator: U.S. Food and Drug Administration
Published: 1988-02-24

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K880650 for HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS, Substantially Equivalent on 1988-02-24. Applicant: Baxter Healthcare Corp. Device class: 1.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1988-02-17
Decision date: 1988-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, 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.