ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES— 510(k) K061663
Substantially EquivalentRtc 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. Device class: 2.
Clearance details
- Applicant
- Rtc Inc.-Memcath Technologies, LLC
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West St. Paul, MN, US
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More clearances from Rtc Inc.-Memcath Technologies, LLC
view allAdverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . 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.