# K011488: Spirabrush CX Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Trylon Corp.
- Decided: Feb 22, 2002 after 283 days
- Product code: HFB (Forceps, Biopsy, Gynecological)
- Device class: 1
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- 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. The FDA summary names no predicate by number.

## Indications for use
SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique. In clinical trials, the SpiraBrush CX biopsy instrument resulted in less frequent need for hemostasis as compared with the standard punch biopsy.

Source page: https://510kreport.com/device/K011488
Methodology: https://510kreport.com/methodology