The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Unidrive S Ii Ent, Drillcut-x Ii-35 Shaver Handpiece, Drillcut-x Ii-35 N Shaver Handpiece.
| Device ID | K200318 |
| 510k Number | K200318 |
| Device Name: | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Contact | Alita Mcelroy |
| Correspondent | Alita Mcelroy Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-07 |
| Decision Date | 2020-10-22 |