# K902622: Manan Prostate Seeding Needle

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Aug 10, 1990 after 57 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 3, 2005 · Not classified · Z-0922-05: The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.

Source page: https://510kreport.com/device/K902622
Methodology: https://510kreport.com/methodology