K161514 is an FDA 510(k) clearance for the Precision Thin Reciprocating Blade, 0.010in.. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on January 17, 2017, 229 days after receiving the submission on June 2, 2016.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.
| 510(k) Number | K161514 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2016 |
| Decision Date | January 17, 2017 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EQJ — Bur, Ear, Nose And Throat |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4140 |