K173111 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 November 28, 2017, 60 days after receiving the submission on September 29, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K173111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2017 |
| Decision Date | November 28, 2017 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET - Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |