Pl-2
Pl-2 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) K092458 on 28 Aug 2009 (1 earlier submission) and listed in FDA GUDID since 29 Apr 2024 (UDI-DI 00860011485407), 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 | Number00860011485407 | Date29 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092458 | Date28 Aug 2009 | StatusActive |
Official records
- AccessGUDID record 00860011485407
- FDA 510(k) database K092458
- FDA 510(k) database K062384
Across registries
- FDA 510(k) K092458 decided 28 Aug 2009 Active
- FDA GUDID UDI-DI 00860011485407 listed 29 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K062384
- Cleared FDA 510(k) K092458
- Listed FDA GUDID 00860011485407
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Manual brachytherapy source, permanent implant
- Model / reference
- PL-2
- Primary DI / UDI-DI
- 00860011485407
- 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
Similar devices
Other devices filed under FDA product code KXK (Source, Brachytherapy, Radionuclide).
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- CivaDerm by CivaTech Oncology Inc.
- ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA by Isoaid, LLC