Sumo Access and Tissue Resection System
510(k) K103155
Sumo Access and Tissue Resection System is a medical device (FDA Class II; FDA product code ODC, Endoscope Channel Accessory) made by Apollo Endosurgery, Inc., cleared under FDA 510(k) K103155 on 28 Oct 2011, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103155 | Date28 Oct 2011 | StatusActive |
Official records
- FDA 510(k) database K103155
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ODC
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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