GUARDIAN FORCEP— 510(k) K893636

Name: FDA 510(k) clearance K893636
Creator: U.S. Food and Drug Administration
Published: 1990-04-09

Substantially Equivalent

Endo-Scientific, Inc.

FDA 510(k) clearance K893636 for GUARDIAN FORCEP, Substantially Equivalent on 1990-04-09. Applicant: Endo-Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Endo-Scientific, Inc.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1989-05-12
Decision date: 1990-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.