K200638 is an FDA 510(k) clearance for the LAP-iX Suction Irrigation. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Sejong Medical Co., Ltd. (Paju-Si, KR). The FDA issued a Cleared decision on April 3, 2020, 24 days after receiving the submission on March 10, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K200638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2020 |
| Decision Date | April 03, 2020 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HET - Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |