# K982659: Medivision Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: Medivision Scope Service Center, Inc.
- Decided: Oct 7, 1998 after 69 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- 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
NOTE: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. Diagnostic Hysteroscopy Abnommal Uterine Bleeding Inferfility & Pregnancy Wastage Evaluation of Abnormal Hysterosalpingogram Intrauterine Foreign Body Amenorrhea Peivic Pain perative Hysteroscopy Directed Blopsy Removal of Submucous Fibroids and Large Polyps Submucous Myomectomy Transection of Intrauterine Adhesions Transection of Intrauterine Septa Endometrial Ablation Medical disease, cervical stenosis, and pelvic infection may alter the choice of focation for hysteroscopy (i.e., office setting vs. Hospital).

Source page: https://510kreport.com/device/K982659
Methodology: https://510kreport.com/methodology