# K960469: Detect Cytology Brush II

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 14, 1996 after 42 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.
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 its predicate without a number.
- (no number) Detect™ Cytology Brush I: named in the summary without a submission number

## Indications for use
The Detect™ Cytology Brush II is a one-time use device for collecting vaginal and cervical cell samples for cytological evaluation and infection diagnosis. The device is not indicated for endometrial cell samipling or for use on pregnant patients.

Source page: https://510kreport.com/device/K960469
Methodology: https://510kreport.com/methodology