Submission Details
| 510(k) Number | K152744 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 2015 |
| Decision Date | June 10, 2016 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
DIEGO ELITE DRILL
Jun 2016
Decision
261d
Days
Class 2
Risk
About This 510(k) Submission
K152744 is an FDA 510(k) clearance for the DIEGO ELITE DRILL, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on June 10, 2016, 261 days after receiving the submission on September 23, 2015. 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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