# K982867: Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: Feb 19, 1999 after 189 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: 2 generations back to K933873 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970078: Hydrofloex HD Hysteroscopic Distention System, Davol Inc., Sub. C. R. Bard, Inc. (1997) Summary page 1.
- K936231: The Karl Storz Hamou Endomat, Karl Storz Endoscopy (1995) Summary page 1.

## Indications for use
The Proposed HydroFlex Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids for diagnostic and/or operative hysteroscopy.

Source page: https://510kreport.com/device/K982867
Methodology: https://510kreport.com/methodology