Cleared Traditional

K955093 - ASPIRATION/COAGULATION ELECTRODE ACE-31...

K955093 is an FDA 510(k) clearance for ASPIRATION/COAGULATION ELECTRODE ACE-31..., manufactured by Utah Medical Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K955093 · Utah Medical Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
174d
Days
Class 2
Risk

K955093 is an FDA 510(k) clearance for the ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511. Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on April 29, 1996 after a review of 174 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4120 - 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.

View all Utah Medical Products, Inc. devices

FDA 510(k) Submission Details - K955093

510(k) Number K955093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1995
Decision Date April 29, 1996
Days to Decision 174 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
14d slower than avg
Panel avg: 160d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGI Device Classification - Class 2, Special Controls

Product Code HGI Electrocautery, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4120
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 - HGI Electrocautery, Gynecologic (and Accessories)

All 25
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K955093.
WALLACH INTEGRATION UNIT
K963348 · Wallach Surgical Devices, Inc. · Mar 1997
KSEA THERMOCOAGULATOR (MODEL 265100 20)
K963852 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
K955756 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
LEEP SYSTEM 1000
K952483 · CooperSurgical, Inc. · Oct 1995
WALLACH LEAP 100 ELECTRO SURGERY SYSTEM
K921791 · Wallach Surgical Devices, Inc. · May 1995
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
K942986 · Aaron Medical Industries · Mar 1995