Inrad 601615
by Inrad
Inrad 601615 is a Class II device made by Inrad, cleared under FDA 510(k) K981721 on 28 Jul 1998 and listed in FDA GUDID since 1 Dec 2016 (UDI-DI 00817295020893), 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 | Number00817295020893 | Date1 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981721 | Date28 Jul 1998 | StatusActive |
Official records
- AccessGUDID record 00817295020893
- FDA 510(k) database K981721
Across registries
- FDA 510(k) K981721 decided 28 Jul 1998 Active
- FDA GUDID UDI-DI 00817295020893 listed 1 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K981721
- Listed FDA GUDID 00817295020893
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Inrad
- Generic name
- Soft-tissue biopsy needle, single-use
- Model / reference
- 601615
- Primary DI / UDI-DI
- 00817295020893
- 510(k) Number
- FDA product code
- KNW
- GMDN term
- Soft-tissue biopsy needle, single-use
- Device class
- Class II
- Regulation number
- 876.1075
- GUDID distribution status
- In Commercial Distribution
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