SOLCOVAC WOUND DRAINAGE SYSTEM— 510(k) K915867

Name: FDA 510(k) clearance K915867
Creator: U.S. Food and Drug Administration
Published: 1992-08-14

Unknown

Solco Basle, Inc.

FDA 510(k) clearance K915867 for SOLCOVAC WOUND DRAINAGE SYSTEM, Unknown on 1992-08-14. Applicant: Solco Basle, Inc.. Device class: 1.

Clearance details

Applicant: Solco Basle, Inc.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1991-12-31
Decision date: 1992-08-14
Decision: Unknown
Clearance type: Traditional
Location: Hingham, MA, US

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K896857 — SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM1990-04-05
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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.