EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7— 510(k) K061324

Substantially Equivalent

Rtc Inc.-Memcath Technologies, LLC

FDA 510(k) clearance K061324 for EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7, Substantially Equivalent on 2006-06-20. Applicant: Rtc Inc.-Memcath Technologies, LLC.

Clearance details

Applicant: Rtc Inc.-Memcath Technologies, LLC
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2006-05-11
Decision date: 2006-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West St. Paul, MN, US

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Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.