KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
Device Facts
| Record ID | K003994 |
|---|---|
| Device Name | KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product Code | ERL · Ear, Nose, Throat |
| Decision Date | Apr 13, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.
