Standard Trocar ST19-1
Standard Trocar ST19-1 is a Class II device made by Standard Bariatrics, cleared under FDA 510(k) K200517 on 9 Apr 2020 and listed in FDA GUDID since 27 Apr 2020 (UDI-DI 00851677007041), 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 | GUDID listing GUDID | Number00851677007041 | Date27 Apr 2020 | StatusListed |
| United States | FDA 510(k) 510(k) | NumberK200517 | Date9 Apr 2020 | StatusActive |
Official records
- AccessGUDID record 00851677007041
- FDA 510(k) database K200517
Across registries
- FDA 510(k) K200517 decided 9 Apr 2020 Active
- FDA GUDID UDI-DI 00851677007041 listed 27 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K200517
- Listed FDA GUDID 00851677007041
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Standard Trocar
- Generic name
- Laparoscopic access cannula, single-use
- Model / Ref / Catalog
- ST19-1, ST19
- Primary DI / UDI-DI
- 00851677007041
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Laparoscopic access cannula, single-use
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Laparoscopic access cannula, single-use.