Instinct G24653
Instinct G24653 (INSC-7-230) is a Class II device made by Cook Incorporated, cleared under FDA 510(k) K132809 on 25 Oct 2013 and listed in FDA GUDID since 3 Nov 2015 (UDI-DI 00827002246539), active as of 23 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 | Number00827002246539 | Date3 Nov 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132809 | Date25 Oct 2013 | StatusActive |
Official records
- AccessGUDID record 00827002246539
- FDA 510(k) database K132809
Across registries
- FDA 510(k) K132809 decided 25 Oct 2013 Active
- FDA GUDID UDI-DI 00827002246539 listed 3 Nov 2015 Listed
Timeline
- Cleared FDA 510(k) K132809
- Listed FDA GUDID 00827002246539
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Instinct
- Generic name
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
- Model / Ref / Catalog
- G24653, INSC-7-230
- Primary DI / UDI-DI
- 00827002246539
- 510(k) Number
- FDA product code
- PKL
- GMDN term
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 876.4400
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Gastrointestinal endoscopic clip, long-term, non-bioabsorbable.