K193652 is an FDA 510(k) clearance for the AbClose - Port Site Closure Device. This device is classified as a Endoscopic Tissue Approximation Device (Class II - Special Controls, product code OCW).
Submitted by Medeon Biodesign, Inc. (Taipei, TW). The FDA issued a Cleared decision on March 26, 2020, 87 days after receiving the submission on December 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 | K193652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2019 |
| Decision Date | March 26, 2020 |
| Days to Decision | 87 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. |