K202688 is an FDA 510(k) clearance for the AFS Medical Sterile Single-Use Access Port System. This device is classified as a Laparoscopic Single Port Access Device (Class II - Special Controls, product code OTJ).
Submitted by Afs Medical Co. , Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on October 14, 2021, 394 days after receiving the submission on September 15, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery..
| 510(k) Number | K202688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2020 |
| Decision Date | October 14, 2021 |
| Days to Decision | 394 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OTJ - Laparoscopic Single Port Access Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery. |