K050256 is an FDA 510(k) clearance for the APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR, a Retractor (Class I — General Controls, product code GAD), submitted by Apple Medical Corp. (Boston, US). The FDA issued a Cleared decision on April 26, 2005, 82 days after receiving the submission on February 3, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K050256 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 03, 2005 |
| Decision Date | April 26, 2005 |
| Days to Decision | 82 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 |