510(k) K080050
K080050 is an FDA 510(k) premarket notification submitted by Spirus Medical, Inc. for the device "SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE". The FDA issued a decision of Substantially Equivalent on May 6, 2008. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Spirus Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2008
- Date Received
- January 8, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Access Overtube, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.