Cleared Traditional

K953453 - SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROL...

K953453 is an FDA 510(k) clearance for SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROL..., manufactured by Symbiosis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K953453 · Symbiosis Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
182d
Days
Class 2
Risk

K953453 is an FDA 510(k) clearance for the SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 182 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Symbiosis Corp. devices

FDA 510(k) Submission Details - K953453

510(k) Number K953453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1995
Decision Date January 17, 1996
Days to Decision 182 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 130d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

Product Code FAS Electrode, Electrosurgical, Active, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAS Electrode, Electrosurgical, Active, Urological

All 28
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K953453.
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
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ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
K955531 · Arthrocare Corp. · Feb 1996
ROLLER ELECTRODE
K951863 · Olympus America, Inc. · Aug 1995
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
K944795 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
K931763 · Olympus Corp. · Aug 1994