# K964136: Hystero CO2-Pneu 2221

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jan 10, 1997 after 87 days
- Product code: HIG (Insufflator, Hysteroscopic)
- Device class: 2
- Regulation: 21 CFR 884.1700
- 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 K880314 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880314: Hysteroscope Autonom 4992, Richard Wolf Medical Instruments Corp. (1988) Summary page 1.
- K924523: Hys-Surgiflator, W.O.M. World of Medicine GmbH (1995) Summary page 1.
- (no number) Hysteroscopy-Insufflator 2020: named in the summary without a submission number
- (no number) Hamou-Micro-Hysteroflator: named in the summary without a submission number
- (no number) Hystero-Insufflator Electronic: named in the summary without a submission number

## Indications for use
The Hystero CO₂-Pneu is designed for dilating the cavum uteri with CO₂ gas during diagnostic and operative hysteroscopy.

Source page: https://510kreport.com/device/K964136
Methodology: https://510kreport.com/methodology