# K971492: Automatic Electronic Hysteroscopic Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Bei Medical Systems Co., Inc.
- Decided: Sep 5, 1997 after 134 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
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 its predicate without a number.
- (no number) Hamou Microhysteroflator - Karl Storz: named in the summary without a submission number
- (no number) Hystero-insufflator Electronic - Wisap: named in the summary without a submission number

## Indications for use
This device is intended to distend the uterus by filling the uterine cavity with CO₂ gas to facilitate viewing with a hysteroscope.

Source page: https://510kreport.com/device/K971492
Methodology: https://510kreport.com/methodology