# K981637: Integrated Drive/Pump System for Otolaryngology

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jul 20, 1998 after 73 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
Longest line of descent: 3 generations back to K862807 (1986). 12 ancestors in all.
478 later devices descend from it; 1 cites it directly.
1 of 491 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971059: Universal Drive System, Linvatec Corp. (1997) Summary page 4.
- K961192: Irrigation System, Linvatec Corp. (1996) Summary page 4.
- K852143: Hall Irrigation System, Hall Surgical, Division of Zimmer, Inc. (1985) Summary page 4.
- K943569: Stryker Total Performance System, Stryker Corp. (1995) Summary page 4.
- K943589: Stryker Total Performance System, Stryker Corp. (1994) Summary page 4.
- K952681: Stryker Hummer II Microdebrider System, Stryker Endoscopy (1995) Summary page 6.

## Most influential descendants
- 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
- K081475: Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] (2008), 443 descendants of its own

## Indications for use
The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and Dbone. The field of application is Otolaryngology surgical procedures.

Source page: https://510kreport.com/device/K981637
Methodology: https://510kreport.com/methodology