K211490 is an FDA 510(k) clearance for the Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000. This device is classified as a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II - Special Controls, product code ERL).
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on June 9, 2021, 27 days after receiving the submission on May 13, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K211490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2021 |
| Decision Date | June 09, 2021 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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 |