# K970078: Hydrofloex HD Hysteroscopic Distention System

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: Dec 11, 1997 after 336 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 K933873 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933873: Concept Universal Pump System, Linvatec Corp. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K901068: Zimmer CDIS Controlled Distention Irrigation System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K982867: Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000 (1999), 0 descendants of its own

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

Source page: https://510kreport.com/device/K970078
Methodology: https://510kreport.com/methodology