K171840 is an FDA 510(k) clearance for the Stryker Consolidated Operating Room Equipment (CORE) 2 Console. 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 September 15, 2017, 87 days after receiving the submission on June 20, 2017.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K171840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2017 |
| Decision Date | September 15, 2017 |
| Days to Decision | 87 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 |