K073255 is an FDA 510(k) clearance for the XPS 3000 SYSTEM. This device is classified as a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II - Special Controls, product code ERL).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 24, 2008, 126 days after receiving the submission on November 19, 2007.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4250.
| 510(k) Number | K073255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2007 |
| Decision Date | March 24, 2008 |
| Days to Decision | 126 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 |