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 | K173111 |
| 510k Number | K173111 |
| 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. 690 Roosevelt 690 Roosevelt, CA 92620 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-11-28 |
| Summary: | summary |