# K991827: Ginram Specuvag, Ginram Specuvag as, Ginram Cuscovag, Models 720101, 720102, 720103, 720179, 720227, 720043

- Pathway: 510(k) (Traditional)
- Applicant: Ri Mos. S.R.L.
- Decided: Jul 19, 1999 after 52 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- 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 K941272 (1994). 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)
- K941272: Kleenspec, Welch Allyn, Inc. (1994) Summary page 1.

## Indications for use
The RI MOS. s.r.l. Cuscovag, Specuvag and Specuvag AS devices are used to expose the interior of the vagina. The Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal.

Source page: https://510kreport.com/device/K991827
Methodology: https://510kreport.com/methodology