Supercath 5
by Togo Medikit Co., Ltd. 2 variants
510(k) K190001
Supercath 5 is a Class II device made by Togo Medikit Co., Ltd., cleared under FDA 510(k) K190001 on 20 Sep 2019, 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 | NumberK190001 | Date20 Sep 2019 | StatusActive |
Official records
- FDA 510(k) database K190001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FOZ
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent