K182873 is an FDA 510(k) clearance for the STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 10, 2019, 90 days after receiving the submission on October 12, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K182873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2018 |
| Decision Date | January 10, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW — Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4840 |