510(k) K231298
K231298 is an FDA 510(k) premarket notification submitted by Alesi Surgical, Ltd. for the device "Ultravision2 System Integrated Monopolar L-Hook (H/S)". The FDA issued a decision of Substantially Equivalent on October 31, 2023. The device falls under product code PQM (Surgical Smoke Precipitator), a Class II device regulated under 21 CFR 878.5050. Alesi Surgical, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2023
- Date Received
- May 4, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Smoke Precipitator
- Device Class
- Class II
- Regulation Number
- 878.5050
- Review Panel
- HO
- Submission Type
The device is intended to precipitate surgical smoke to allow surgeons adequately visualize laparoscopic surgeries in the using surgical smoke/aerosolized particulate surgical tools.