Pl-4NS
Pl-4NS is a manual brachytherapy source (FDA Class II; FDA product code KXK, Source, Brachytherapy, Radionuclide) made by GT Medical Technologies, cleared under FDA 510(k) K062384 on 9 Nov 2006 and listed in FDA GUDID since 29 Apr 2024 (UDI-DI 00860011485438), active as of 6 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 | Number00860011485438 | Date29 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062384 | Date9 Nov 2006 | StatusActive |
Official records
- AccessGUDID record 00860011485438
- FDA 510(k) database K062384
Across registries
- FDA 510(k) K062384 decided 9 Nov 2006 Active
- FDA GUDID UDI-DI 00860011485438 listed 29 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K062384
- Listed FDA GUDID 00860011485438
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Manual brachytherapy source, permanent implant
- Model / reference
- PL-4NS
- Primary DI / UDI-DI
- 00860011485438
- 510(k) Number
- FDA product code
- KXK
- GMDN term
- Manual brachytherapy source, permanent implant
- Device class
- Class II
- Regulation number
- 892.5730
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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Other devices filed under FDA product code KXK (Source, Brachytherapy, Radionuclide).
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