Cleared Traditional

K982739 - GYNEX ELECTRODES

K982739 is an FDA 510(k) clearance for GYNEX ELECTRODES, manufactured by Gynex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K982739 · Gynex Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
218d
Days
Class 2
Risk

K982739 is an FDA 510(k) clearance for the GYNEX ELECTRODES. Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by Gynex Corp. (Pleasant Hill, US). The FDA issued a Cleared decision on March 12, 1999 after a review of 218 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 Gynex Corp. devices

FDA 510(k) Submission Details - K982739

510(k) Number K982739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date March 12, 1999
Days to Decision 218 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 160d · This submission: 218d
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 26
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K982739.
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K983840 · Wallach Surgical Devices, Inc. · May 1999
ROCKET ELECTRODE
K974138 · A & A Medical, Inc. · Jan 1998
VALLEY FORGE BIPOLAR LOOP
K971986 · Valley Forge Scientific Corp. · Aug 1997
TBD
K965245 · Utah Medical Products, Inc. · Jul 1997