# K182049: exCellerator Cervical Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Excell Company, LLC
- Decided: Apr 25, 2019 after 268 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
Longest line of descent: 1 generation back to K861389 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861389: Pap Smear Kit, Intl. Cytobrush, Inc. (1986) Summary page 4.

## Indications for use
The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.

Source page: https://510kreport.com/device/K182049
Methodology: https://510kreport.com/methodology