CATHETERS, DRAINAGE— 510(k) K771048

Name: FDA 510(k) clearance K771048
Creator: U.S. Food and Drug Administration
Published: 1977-07-19

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K771048 for CATHETERS, DRAINAGE, Substantially Equivalent on 1977-07-19. Applicant: Axiom Medical, Inc.. Device class: 2.

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code FEG
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1977-06-10
Decision date: 1977-07-19
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 FEG

product code FEG

Death: 2
Total: 2

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.