A.W.E.L.— 510(k) K943614

Name: FDA 510(k) clearance K943614
Creator: U.S. Food and Drug Administration
Published: 1995-01-04

Substantially Equivalent

Medi-Flex

FDA 510(k) clearance K943614 for A.W.E.L., Substantially Equivalent on 1995-01-04. Applicant: Medi-Flex. Device class: 2.

Clearance details

Applicant: Medi-Flex
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-27
Decision date: 1995-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Islandia, NY, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.