K022989 is an FDA 510(k) clearance for the RADLITE TISSUE RETRACTOR SYSTEM, a Light, Surgical, Endoscopic (Class II — Special Controls, product code FSW), submitted by Genzyme Biosurgery (Fall River, US). The FDA issued a Cleared decision on November 25, 2002, 77 days after receiving the submission on September 9, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K022989 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 2002 |
| Decision Date | November 25, 2002 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSW — Light, Surgical, Endoscopic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |