Btl-299-F
510(k) K262353
Btl-299-F is a Class II device made by BTL Industries, Inc., cleared under FDA 510(k) K262353 on 23 Sep 2026, 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 | NumberK262353 | Date23 Sep 2026 | StatusActive |
Official records
- FDA 510(k) database K262353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPI
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5320
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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