Submission Details
| 510(k) Number | K211490 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
Jun 2021
Decision
27d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 874.4250.
Device Classification
| Product Code | ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.4250 |
Manufacturer
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