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FDA 510(k), K122270, OVERTUBE ENDOSCOPIC ACCESS SYSTEM
FDA 510(k), K122270, OVERTUBE ENDOSCOPIC ACCESS SYSTEM
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510(K) Number: K122270
Device Name: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
Manufacturer: APOLLO ENDOSURGERY, INC.
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 07/30/2012
Decision Date: 09/28/2012
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
Manufacturer: APOLLO ENDOSURGERY, INC.
Device Classification Name: endoscopic access overtube, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 07/30/2012
Decision Date: 09/28/2012
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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