K191439 is an FDA 510(k) clearance for the OverStitch 2-0 Polypropylene Suture. This device is classified as a Endoscopic Tissue Approximation Device (Class II - Special Controls, product code OCW).
Submitted by Apollo Endosurgery (Austin, US). The FDA issued a Cleared decision on August 29, 2019, 91 days after receiving the submission on May 30, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue..
| 510(k) Number | K191439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2019 |
| Decision Date | August 29, 2019 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OCW - Endoscopic Tissue Approximation Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue. |