PAK Needle MP6001
PAK Needle MP6001 is a Class II device made by Izi Medical Products LLC, cleared under FDA 510(k) K142344 on 20 Mar 2015 and listed in FDA GUDID since 24 May 2021 (UDI-DI 00815212022920), 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 | Number00815212022920 | Date24 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142344 | Date20 Mar 2015 | StatusActive |
Official records
- AccessGUDID record 00815212022920
- FDA 510(k) database K142344
Across registries
- FDA 510(k) K142344 decided 20 Mar 2015 Active
- FDA GUDID UDI-DI 00815212022920 listed 24 May 2021 Listed
Timeline
- Cleared FDA 510(k) K142344
- Listed FDA GUDID 00815212022920
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PAK Needle
- Generic name
- Stereotactic surgery system probe, single-use
- Model / reference
- MP6001
- Primary DI / UDI-DI
- 00815212022920
- 510(k) Number
- FDA product code
- HAW
- GMDN term
- Stereotactic surgery system probe, single-use
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
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