ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES— 510(k) K061663

Substantially Equivalent

Rtc Inc.-Memcath Technologies, LLC

FDA 510(k) clearance K061663 for ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES, Substantially Equivalent on 2006-09-06. Applicant: Rtc Inc.-Memcath Technologies, LLC.

Clearance details

Applicant: Rtc Inc.-Memcath Technologies, LLC
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2006-06-05
Decision date: 2006-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West St. Paul, MN, US

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Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.