# K983202: Harwill Medical Cervitula Cervical Spatula

- Pathway: 510(k) (Traditional)
- Applicant: Harwill Medical (Pty), Ltd.
- Decided: Mar 15, 1999 after 182 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Harwill Medical Cervitula is a disposable cervical spatula that is used to collect endo and ectocervical cells for Pap smear analysis and/or for sexually transmitted disease (STD) testing. The Harwill Medical Cervitula is not intended for use in pregnant women. Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K983202
Methodology: https://510kreport.com/methodology