Tubeclear
510(k) K121571
Tubeclear is a medical device (FDA Class II; FDA product code KNT, Tubes, Gastrointestinal (And Accessories)) made by Actuated Medical, Inc., cleared under FDA 510(k) K121571 on 13 Jun 2012, 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 | NumberK121571 | Date13 Jun 2012 | StatusActive |
Official records
- FDA 510(k) database K121571
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNT
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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