# K990213: Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set

- Pathway: 510(k) (Special)
- Applicant: Gyrus Ent LLC
- Decided: Feb 2, 1999 after 11 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- 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 K932988 (1993). 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)
- K973286: Ent Irrigating Pump (70327700), Gyrus Ent LLC (1997) Summary page 1.
- K932988: Accessories for Endoscopes for Sinus Surgery, Smith & Nephew Richards, Inc. (1993) Summary page 1.

## Indications for use
The HydraClear System is intended for endoscopic sinus surgery, to irrigate the surgical site, and for the removal of blood and tissue deposits from the surface of the sinusope lens.

Source page: https://510kreport.com/device/K990213
Methodology: https://510kreport.com/methodology