Pathfinder Endoscope Cap
510(k) K210915
Pathfinder Endoscope Cap is a Class II device made by Neptune Medical, Inc., cleared under FDA 510(k) K210915 on 25 May 2021, 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 | NumberK210915 | Date25 May 2021 | StatusActive |
Official records
- FDA 510(k) database K210915
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FDS
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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