# K023073: Seed Link

- Pathway: 510(k) (Traditional)
- Applicant: Implant Sciences Corp.
- Decided: Apr 7, 2003 after 203 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 K940632 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940632: I-125 Rapid Strand, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1994) Summary page 1.
- K011155: Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S, Ibt, Inc. (2001)

## Most influential descendants
- K053595: Curay Custom Seed Array (2006), 0 descendants of its own

## Indications for use
Implant Sciences '2SIodine Brachytherapy Seeds with individual activities from 0.1 to 5.0 mCi are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment, such as for prostate cancer or for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors. Seed Link may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible @mors are commonly treated.

Source page: https://510kreport.com/device/K023073
Methodology: https://510kreport.com/methodology