Cleared Traditional

SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES (K953242) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953242 · Symbiosis Corp. · Obstetrics & Gynecology device
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Oct 1995
Decision
87d
Days
Class 2
Risk

K953242 is an FDA 510(k) clearance for the SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 87 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 Symbiosis Corp. devices

Submission Details

510(k) Number K953242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1995
Decision Date October 06, 1995
Days to Decision 87 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
73d faster than avg
Panel avg: 160d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K953242.
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VAPORIZATION ELECTRODES
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KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
K944862 · KARL STORZ Endoscopy-America, Inc. · Feb 1995
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
K944793 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ INSULATED SCISSORS
K944297 · KARL STORZ Endoscopy-America, Inc. · Dec 1994