Submission Details
| 510(k) Number | K150728 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 20, 2015 |
| Decision Date | August 14, 2015 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
Aug 2015
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K150728 is an FDA 510(k) clearance for the XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole, 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 August 14, 2015, 147 days after receiving the submission on March 20, 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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