K980588 is an FDA 510(k) clearance for the CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000, a Retractor (Class I — General Controls, product code GAD), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 18, 1998, 182 days after receiving the submission on February 17, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K980588 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 17, 1998 |
| Decision Date | August 18, 1998 |
| Days to Decision | 182 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 |