Arrow IPN033841
Arrow IPN033841 (AK-01601) is a Class I device made by Teleflex Incorporated, cleared under FDA 510(k) K895516 on 27 Dec 1989 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00801902004826), 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 | Number00801902004826 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK895516 | Date27 Dec 1989 | StatusActive |
Official records
- AccessGUDID record 00801902004826
- FDA 510(k) database K895516
Across registries
- FDA 510(k) K895516 decided 27 Dec 1989 Active
- FDA GUDID UDI-DI 00801902004826 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K895516
- Listed FDA GUDID 00801902004826
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arrow
- Generic name
- Incision/drainage kit
- Model / Ref / Catalog
- IPN033841, AK-01601
- Primary DI / UDI-DI
- 00801902004826
- 510(k) Number
- FDA product code
- GBX
- GMDN term
- Incision/drainage kit
- Device class
- Class I
- Regulation number
- 878.4200
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Incision/drainage kit.