# K150969: Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America, Inc.
- Decided: Jan 8, 2016 after 270 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: 1 generation back to K053262 (2005). 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)
- K053262: Ksea Unidrive Ent/Neuro/Omfs System and Accessories, KARL STORZ Endoscopy-America, Inc. (2005) Summary page 4.

## Most influential descendants
- K200318: UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece (2020), 0 descendants of its own

## Indications for use
The UNIDRIVE® S I1I ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpiece. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.

Source page: https://510kreport.com/device/K150969
Methodology: https://510kreport.com/methodology