# K980237: Gynex Endospeculum

- Pathway: 510(k) (Traditional)
- Applicant: Gynex Corp.
- Decided: Apr 8, 1998 after 75 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- 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) Kogan Endospeculum: named in the summary without a submission number

## Indications for use
1. Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the wurethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.

Source page: https://510kreport.com/device/K980237
Methodology: https://510kreport.com/methodology