Cleared Traditional

K231298 - Ultravision2 System Integrated Monopola...

K231298 is an FDA 510(k) clearance for Ultravision2 System Integrated Monopola..., manufactured by Alesi Surgical, Ltd.. The device is a Class 2 General Hospital device with product code PQM cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K231298 · Alesi Surgical, Ltd. · General Hospital
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Oct 2023
Decision
180d
Days
Class 2
Risk

K231298 is an FDA 510(k) clearance for the Ultravision2™ System Integrated Monopolar L-Hook (H/S)™. Classified as Surgical Smoke Precipitator (product code PQM), Class II - Special Controls.

Submitted by Alesi Surgical, Ltd. (Cardiff, GB). The FDA issued a Cleared decision on October 31, 2023 after a review of 180 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5050 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Alesi Surgical, Ltd. devices

FDA 510(k) Submission Details - K231298

510(k) Number K231298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2023
Decision Date October 31, 2023
Days to Decision 180 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 129d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PQM Device Classification - Class 2, Special Controls

Product Code PQM Surgical Smoke Precipitator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5050
Definition The Device Is Intended To Precipitate Surgical Smoke To Allow Surgeons Adequately Visualize Laparoscopic Surgeries In The Using Surgical Smoke/aerosolized Particulate Surgical Tools.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.