# K213207: Sheath, Stopcock Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Dec 22, 2021 after 84 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
Longest line of descent: 1 generation back to K943713 (1995). 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)
- K943713: Torcars,Cannulae,Sheaths,Obturators, Karl Storz Endoskop GmbH (1995) Summary page 5.

## Indications for use
Sheath with integrated stopcocks are used in conjunction with a hysteroscope to permit direct viewing of the cervical canal and the uterine cavity to perform diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K213207
Methodology: https://510kreport.com/methodology