# K092458: Proxcelan CS-131PRELOADED Strands, Model PL-1, Proxcelan CS-131 Preloaded Strands in 18 Guage Needles, Model PL-2

- Pathway: 510(k) (Special)
- Applicant: Isoray Medical, Inc.
- Decided: Aug 28, 2009 after 17 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.
1 later device descends from it; 1 cites it directly.
0 of 26 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
- K202267: Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles (2020), 0 descendants of its own

## Indications for use
Proxcelan TM (Cesium-1 31) Implant Devices 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/K092458
Methodology: https://510kreport.com/methodology