510(k) K200638
K200638 is an FDA 510(k) premarket notification submitted by Sejong Medical Co., Ltd. for the device "LAP-iX Suction Irrigation". The FDA issued a decision of Substantially Equivalent on April 3, 2020. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Sejong Medical Co., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2020
- Date Received
- March 10, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type