K034004 is an FDA 510(k) clearance for the DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE. This device is classified as a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II - Special Controls, product code ERL).
Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on March 3, 2004, 70 days after receiving the submission on December 24, 2003.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K034004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2003 |
| Decision Date | March 03, 2004 |
| Days to Decision | 70 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 |