# K963685: Eos Brand Disposable Cyto/Cervical Sampler

- Pathway: 510(k) (Traditional)
- Applicant: North Eos Industries, Inc.
- Decided: Oct 11, 1996 after 38 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) Aver's spatula (wooden): named in the summary without a submission number
- (no number) Aver's spatula (plastic): named in the summary without a submission number
- (no number) Cyco-Brush: named in the summary without a submission number
- (no number) cervi-brush: named in the summary without a submission number
- (no number) Endocarvical sampler: named in the summary without a submission number
- (no number) Cotton Swab: named in the summary without a submission number
- (no number) CYeoPick: named in the summary without a submission number
- (no number) WY noscatin: named in the summary without a submission number
- (no number) spatulias and cokton Swads (Paul Boettger ong company): named in the summary without a submission number
- (no number) veo-spatula for cervical smear: named in the summary without a submission number

## Indications for use
The device-EosSmear is the Ayer's spatula type with screw round top for easily scraping and removing the cytoleogical material from the surface of the cervix or vagina; and the back of the design is for scraping also of the cervical area and SCJ part of the body.

Source page: https://510kreport.com/device/K963685
Methodology: https://510kreport.com/methodology