# K971518: Ksea Semi-Rigid Hysteroscope and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jul 24, 1997 after 90 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. The FDA summary names no predicate by number.

## Indications for use
The Karl Storz Semi-Rigid Hysteroscope and Accessories are indicated in the following conditions: Diagnostic abnormal uterine bleeding iofertiity and pregnancy wastage intrauterine foreign body pelvic pain monitoring of IUD status evaluation of abnormal hysterosalpingogram evaluatiod of abnormalities of the endometrium Operative directed biopsy transection of intrauternine septa transection of intrauterine adhesions

Source page: https://510kreport.com/device/K971518
Methodology: https://510kreport.com/methodology