SERIES 400 GASTROENTEROLOGY SYSTEM— 510(k) K944620

Substantially Equivalent

Marks & Murase

FDA 510(k) clearance K944620 for SERIES 400 GASTROENTEROLOGY SYSTEM, Substantially Equivalent on 1995-04-27. Applicant: Marks & Murase.

Clearance details

Applicant: Marks & Murase
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-20
Decision date: 1995-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.