K100593 is an FDA 510(k) clearance for the SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME. This device is classified as a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II - Special Controls, product code GAW).
Submitted by Lsi Solutions, Inc. (Victor, US). The FDA issued a Cleared decision on October 13, 2010, 225 days after receiving the submission on March 2, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5010.
| 510(k) Number | K100593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2010 |
| Decision Date | October 13, 2010 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAW - Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5010 |