Cleared Traditional

K132184 - ACESSA GUIDANCE HANDPIECE

K132184 is an FDA 510(k) clearance for ACESSA GUIDANCE HANDPIECE, manufactured by Halt Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFG cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K132184 · Halt Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
287d
Days
Class 2
Risk

K132184 is an FDA 510(k) clearance for the ACESSA GUIDANCE HANDPIECE. Classified as Coagulator, Laparoscopic, Unipolar (and Accessories) (product code HFG), Class II - Special Controls.

Submitted by Halt Medical, Inc. (Brentwood, US). The FDA issued a Cleared decision on April 28, 2014 after a review of 287 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.

FDA 510(k) Submission Details - K132184

510(k) Number K132184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date April 28, 2014
Days to Decision 287 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 161d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HFG Coagulator, Laparoscopic, Unipolar (and Accessories)

All 9
Devices cleared under the same product code (HFG) and FDA review panel - the closest regulatory comparables to K132184.
Acessa ProVu System
K181124 · Acessa Health, Inc. · Sep 2018
ACESSA GUIDANCE SYSTEM
K132744 · Halt Medical, Inc. · May 2014
THE ABLATION SYSTEM
K121858 · Halt Medical, Inc. · Nov 2012
MICROMED PD-8K INSULATION DEFECT DETECTOR
K101606 · Mcgan Technology, LLC · Oct 2010
INSULSCAN INSULATION TESTING SYSTEM
K991424 · Medicor Corp. · Jul 1999
ENDO-TECH LTD., TIPS
K961695 · Ratio Design Lab · Jul 1996
K132184 · ACESSA GUIDANCE HANDPIECE
Download PDF FDA Summary Halt Medical, Inc.