The following data is part of a premarket notification filed by Afs Medical Co. Ltd. with the FDA for Afs Medical Sterile Single-use Access Port System.
| Device ID | K202688 |
| 510k Number | K202688 |
| Device Name: | AFS Medical Sterile Single-Use Access Port System |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | AFS Medical Co. Ltd. Na-131, Ezen Mecha Zone, 117 Hwanggeum-ro, Yangchon-eup, Gimpo-si Gyeonggi-do, KR 10048 |
| Contact | Min Ah Kim |
| Correspondent | Michele Lucey Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-15 |
| Decision Date | 2021-10-14 |