# K961605: Karl Storz 10.5 FR. Flexible Hysteroscope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 13, 1996 after 202 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- May 21, 2026 · Class II · Z-2794-2026: Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance

## Indications for use
The KSEA flexible hysteroscope is intended for hysteroscopy.

Source page: https://510kreport.com/device/K961605
Methodology: https://510kreport.com/methodology