K983647 is an FDA 510(k) clearance for the ECHO-COAT ULTRASOUND NEEDLES, a Device, Percutaneous, Biopsy (Class I — General Controls, product code MJG), submitted by Sts Biopolymers (Rockville, US). The FDA issued a Cleared decision on January 20, 1999, 96 days after receiving the submission on October 16, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K983647 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 16, 1998 |
| Decision Date | January 20, 1999 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MJG — Device, Percutaneous, Biopsy |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |