CULDOCENTESIS TRAY— 510(k) K780624

Name: FDA 510(k) clearance K780624
Creator: U.S. Food and Drug Administration
Published: 1978-05-26

Substantially Equivalent

Cutter Laboratories, Inc.

FDA 510(k) clearance K780624 for CULDOCENTESIS TRAY, Substantially Equivalent on 1978-05-26. Applicant: Cutter Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Cutter Laboratories, Inc.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1978-04-14
Decision date: 1978-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.