Cleared Traditional

K974138 - ROCKET ELECTRODE

K974138 is an FDA 510(k) clearance for ROCKET ELECTRODE, manufactured by A & A Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974138 · A & A Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
88d
Days
Class 2
Risk

K974138 is an FDA 510(k) clearance for the ROCKET ELECTRODE. Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A & A Medical, Inc. devices

FDA 510(k) Submission Details - K974138

510(k) Number K974138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1997
Decision Date January 30, 1998
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 33
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K974138.
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GYNEX ELECTRODES
K982739 · Gynex Corp. · Mar 1999
VALLEY FORGE BIPOLAR LOOP
K971986 · Valley Forge Scientific Corp. · Aug 1997
TBD
K965245 · Utah Medical Products, Inc. · Jul 1997
WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
K963653 · Wallach Surgical Devices, Inc. · Jun 1997