Submission Details
| 510(k) Number | K121678 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 07, 2012 |
| Decision Date | August 30, 2012 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
DTAD
Aug 2012
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K121678 is an FDA 510(k) clearance for the DTAD, 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 August 30, 2012, 84 days after receiving the submission on June 7, 2012. 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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