K043602 is an FDA 510(k) clearance for the QUADRANT RETRACTOR SYSTEM, a Retractor (Class I — General Controls, product code GAD), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on February 23, 2005, 56 days after receiving the submission on December 29, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K043602 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 2004 |
| Decision Date | February 23, 2005 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAD — Retractor |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |