K200318 is an FDA 510(k) clearance for the UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece. This device is classified as a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II - Special Controls, product code ERL).
Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on October 22, 2020, 258 days after receiving the submission on February 7, 2020.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K200318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2020 |
| Decision Date | October 22, 2020 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4250 |