# K973286: Ent Irrigating Pump (70327700)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Sep 29, 1997 after 27 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Essential Shaver System: named in the summary without a submission number
- (no number) XPS Irrigator Pump: named in the summary without a submission number
- (no number) Endo-Scrub Lens Cleaning System: named in the summary without a submission number

## Most influential descendants
- K990213: Hydraclear Pump Console, Hydraclear Power Supplly, Hydraclear Footswitch, Hydraclear Sheaths, Hydraclear Set (1999), 0 descendants of its own

## Indications for use
The ENTire Irrigating Pump is an accessory to the Smith & Nephew electrically powered surgical drill equipment as well as endoscopic visualization systems. It is intended to provide irrigant in conjunction with general ear, nose and throat/head & neck procedures. This modification offers the surgeon the option of irrigating the surgical site or cleansing the lens of the endoscope during otolaryngologic/otoneurologic/head & neck/ endoscopic procedures.

Source page: https://510kreport.com/device/K973286
Methodology: https://510kreport.com/methodology