# K961192: Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Apr 26, 1996 after 31 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.
479 later devices descend from it; 1 cites it directly.
1 of 480 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981637: Integrated Drive/Pump System for Otolaryngology (1998), 478 descendants of its own
- K990524: E9000 System (1999), 477 descendants of its own
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) (2001), 447 descendants of its own
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery) (2001), 447 descendants of its own
- K012456: Sodem High Speed System (Electric) (Ear, Nose, and Throat) (2001), 446 descendants of its own

Source page: https://510kreport.com/device/K961192
Methodology: https://510kreport.com/methodology