CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS— 510(k) K931670

Name: FDA 510(k) clearance K931670
Creator: U.S. Food and Drug Administration
Published: 1994-01-25

Substantially Equivalent

Carapace, Inc.

FDA 510(k) clearance K931670 for CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS, Substantially Equivalent on 1994-01-25. Applicant: Carapace, Inc.. Device class: 2.

Clearance details

Applicant: Carapace, Inc.
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 1993-04-06
Decision date: 1994-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broken Arrow, OK, US

Download summary PDF View on FDA.gov ↗

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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 CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.