# K053262: Ksea Unidrive Ent/Neuro/Omfs System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Dec 19, 2005 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.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- 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 (2016), 1 descendant of its own
- 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 STAMMBERGER Paranasal Shaver 9 0 Handpiece, the straight Micro-Shaver Handpiece, or the STAMMBERGER-CASTELNUOVO DrillCut-X Shaver Handpiece in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to shave, debride or cut tissue during Head, Neck, ENT and Otoneurological surgical procedures. The KSEA Stammberger-Sachse Intranasal Drill or ENT Drill in conjunction with the UNIDRIVE ENT control unit is a motorized, reusable surgical device system, intended for use by qualified surgeons to provide controlled cutting, drilling, sawing and removal of bone during Head, Neck, ENT and Otoneurological surgical procedures.

Source page: https://510kreport.com/device/K053262
Methodology: https://510kreport.com/methodology