# K992262: Indigo Prostate Seeding Needle Cartridge System

- Pathway: 510(k) (Traditional)
- Applicant: Indigo Medical, Inc.
- Decided: Oct 4, 1999 after 90 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: 1 generation back to K890341 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890341: Mick 200-TP and Mick TP Needle, Mick Radio-Nuclear Instruments, Inc. (1989) Summary page 1.
- K940632: I-125 Rapid Strand, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1994) Summary page 1.
- (no number) LOOK, Inc. Spacing Material: named in the summary without a submission number

## Indications for use
The indigo Prostate Seeding Needle Cartridge System is indicated for use in conjunction with the Indigo Prostate Seeding Needle to deliver a radionuclide brachytherapy source for permanent interstitial implantation in the prostatc gland for the treatment of localized tumors which arc of low to moderate radiosensitivity.

Source page: https://510kreport.com/device/K992262
Methodology: https://510kreport.com/methodology