K102028 is an FDA 510(k) clearance for the NEOTRACT ANCHOR SYSTEM MODEL TAS400. This device is classified as a Suture, Nonabsorbable, Synthetic, Polyethylene (Class II - Special Controls, product code GAT).
Submitted by Neotract, Inc. (Pleasanton, US). The FDA issued a Cleared decision on August 4, 2010, 16 days after receiving the submission on July 19, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5000.
| 510(k) Number | K102028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2010 |
| Decision Date | August 04, 2010 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAT - Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5000 |