Cleared Traditional

K181124 - Acessa ProVu System (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181124 · Acessa Health, Inc. · Obstetrics & Gynecology device
Sep 2018
Decision
151d
Days
Class 2
Risk

K181124 is an FDA 510(k) clearance for the Acessa ProVu System. Classified as Coagulator, Laparoscopic, Unipolar (and Accessories) (product code HFG), Class II - Special Controls.

Submitted by Acessa Health, Inc. (Austin, US). The FDA issued a Cleared decision on September 28, 2018 after a review of 151 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K181124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2018
Decision Date September 28, 2018
Days to Decision 151 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 158d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HFG Coagulator, Laparoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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 Obstetrics & Gynecology devices follow this clearance model.