# K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5

- Pathway: 510(k) (Special)
- Applicant: Isoray Medical, Inc.
- Decided: Aug 7, 2009 after 23 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801748 (1980). 24 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge, Isoray, Inc. (2006) Summary page 1.

## Most influential descendants
- K180515: GammaTile (2018), 3 descendants of its own
- K190296: GammaTile (2019), 2 descendants of its own
- K190839: GammaTile (2020), 1 descendant of its own
- K221539: GammaTile (2022), 0 descendants of its own

## Indications for use
ProxcelanT M (Cesium-1 31) Implant Devices, Model PL-5 - Cs-131 Preloaded Braided Strands, containing cesium-1 31 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment for residual disease after excision of primary tumors.

Source page: https://510kreport.com/device/K092136
Methodology: https://510kreport.com/methodology