# K971849: Cytology Brush

- Pathway: 510(k) (Traditional)
- Applicant: Team Technologies, Inc.
- Decided: Jul 24, 1997 after 66 days
- Product code: HHT (Spatula, Cervical, Cytological)
- Device class: 2
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K980356: Cervical Cytology C-Brush Model CMB-1010 (1998), 0 descendants of its own

## Indications for use
Indications for use are the endocervical collection of specimens used in Pap smear, chlamydia and HPV testing.

Source page: https://510kreport.com/device/K971849
Methodology: https://510kreport.com/methodology