K950007 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT GUIDE, a Guide, Needle, Surgical (Class I — General Controls, product code GDF), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on March 15, 1995, 71 days after receiving the submission on January 3, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K950007 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 03, 1995 |
| Decision Date | March 15, 1995 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDF — Guide, Needle, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |