Identifiers
- 510(k) Number
- K173111 FDA 510(k)
- FDA Product Code
- HET FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1720 FDA 510(k)
- Regulation Number
- 884.1720 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LAP-iX Suction Irrigation is a laparoscope, gynecologic (and accessories) device that provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to the surgical site.
It is supplied as a reusable device for use in obstetrics/gynecology settings. The device has FDA 510(k) clearance under K200638 and is classified as a Class 2 device with product code HET.
Frequently asked questions
What is the LAP-iX Suction Irrigation used for?
The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to the surgical site.
How is the LAP-iX Suction Irrigation supplied and intended for use?
The device is supplied as a reusable device for use in obstetrics/gynecology settings.
What regulatory pathway was used for the LAP-iX Suction Irrigation?
The LAP-iX Suction Irrigation has FDA 510(k) clearance under K200638 and is classified as a Class 2 device with product code HET.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K200638 - LAP-iX Suction Irrigation | FDA 510 (k), PDF Sejong Medical Co., Ltd. -iX a - Food and Drug Administration, Sejong Medical Co., Ltd. FDA 510 (k) Products - Latest 2026, LAP-iX Suction Irrigation (K200638) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173111 | Class II | Active |
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Manufacturer
- Manufacturer
- Sejong Medical Co., Ltd
- FDA Applicant
- Sejong Medical Co., Ltd.
Sources (1)
- FDA 510(k) K173111 24 fields · synced Sep 19, 2026