CARAPACE INSTRUMLENT AND INSTRUMENT SETS— 510(k) K931824

Name: FDA 510(k) clearance K931824
Creator: U.S. Food and Drug Administration
Published: 1993-12-06

Unknown

Carapace, Inc.

FDA 510(k) clearance K931824 for CARAPACE INSTRUMLENT AND INSTRUMENT SETS, Unknown on 1993-12-06. Applicant: Carapace, Inc.. Device class: 2.

Clearance details

Applicant: Carapace, Inc.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1993-04-08
Decision date: 1993-12-06
Decision: Unknown
Clearance type: Traditional
Location: Broken Arrow, OK, US

Download summary PDF View on FDA.gov ↗

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More clearances from Carapace, Inc.

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K931722 — CARAPACE LABOR AND DELIVERY SETS1994-03-23
K931822 — CARAPACE PELVIC EXAM TRAYS1994-03-07
K931729 — I.V. START KIT1994-02-22
K931669 — CARAPACE DEBRIDEMENT KITS1994-02-07
K931820 — CARAPACE STILLWATER BOWL SET1994-02-07

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.