Cleared Traditional

K931338 - 16 ELECTRODES (BLADE

K931338 is the FDA 510(k) clearance for 16 ELECTRODES (BLADE by Aaron Medical Industries. It is a Class 2 Obstetrics & Gynecology device (product code HGI) cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K931338 · Aaron Medical Industries · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
337d
Days
Class 2
Risk

K931338 is an FDA 510(k) clearance for the 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP). Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on February 16, 1994 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aaron Medical Industries devices

Submission Details

510(k) Number K931338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1993
Decision Date February 16, 1994
Days to Decision 337 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 160d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K931338.
ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
K925560 · Zinnanti Surgical Instruments, Inc. · Aug 1994
ELECTROSURGICAL ELECTRODE
K925478 · Megadyne Medical Products, Inc. · Jun 1994
CRYOMEDICS LLETZ LOOPS
K923570 · Cabot Medical Corp. · Feb 1994
SURGISTAT
K922206 · Valleylab, Inc. · Sep 1993
FORCE 2
K921884 · Valleylab, Inc. · Dec 1992
FORCE 1C
K921222 · Valleylab, Inc. · Sep 1992