Submission Details
| 510(k) Number | K073255 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
XPS 3000 SYSTEM
Mar 2008
Decision
126d
Days
Class 2
Risk
About This 510(k) Submission
K073255 is an FDA 510(k) clearance for the XPS 3000 SYSTEM, 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 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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