Cleared Traditional

K971621 - RESISTICK SOLID LAPAROSCOPIC ELECTRODES

K971621 is an FDA 510(k) clearance for RESISTICK SOLID LAPAROSCOPIC ELECTRODES, manufactured by Aaron Medical Industries. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K971621 · Aaron Medical Industries · Obstetrics & Gynecology device
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Jun 1997
Decision
50d
Days
Class 2
Risk

K971621 is an FDA 510(k) clearance for the RESISTICK SOLID LAPAROSCOPIC ELECTRODES. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 50 days - a notably fast clearance 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: 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 Aaron Medical Industries devices

FDA 510(k) Submission Details - K971621

510(k) Number K971621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date June 20, 1997
Days to Decision 50 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
110d faster than avg
Panel avg: 160d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNF Device Classification - Class 2, Special Controls

Product Code KNF Coagulator-cutter, Endoscopic, 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 - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 34
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K971621.
MICRO ELECTRODES
K971838 · CooperSurgical, Inc. · Nov 1997
LAPARETTE
K971146 · Rd Chus, Inc. · Aug 1997
VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
K964594 · Circon Corp. · Aug 1997
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
K964441 · Gynecare Innovation Center · Mar 1997
SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES
K953242 · Symbiosis Corp. · Oct 1995
NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS
K952070 · American Hydro-Surgical Instruments, Inc. · Jul 1995