CARAPACE DEBRIDEMENT KITS— 510(k) K931669

Name: FDA 510(k) clearance K931669
Creator: U.S. Food and Drug Administration
Published: 1994-02-07

Unknown

Carapace, Inc.

FDA 510(k) clearance K931669 for CARAPACE DEBRIDEMENT KITS, Unknown on 1994-02-07. Applicant: Carapace, Inc.. Device class: 2.

Clearance details

Applicant: Carapace, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1993-04-06
Decision date: 1994-02-07
Decision: Unknown
Clearance type: Traditional
Location: Broken Arrow, OK, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.