The following data is part of a premarket notification filed by Sejong Medical Co., Ltd. with the FDA for Lap-ix Suction Irrigation.
| Device ID | K200638 |
| 510k Number | K200638 |
| Device Name: | LAP-iX Suction Irrigation |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, KR 10880 |
| Contact | Yoojung Choi |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2020-04-03 |