Cleared Traditional

K951863 - ROLLER ELECTRODE

K951863 is the FDA 510(k) clearance for ROLLER ELECTRODE by Olympus America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAS) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K951863 · Olympus America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
125d
Days
Class 2
Risk

K951863 is an FDA 510(k) clearance for the ROLLER ELECTRODE. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 125 days - within the typical 510(k) review window.

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 Olympus America, Inc. devices

Submission Details

510(k) Number K951863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date August 24, 1995
Days to Decision 125 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
5d faster than avg
Panel avg: 130d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K951863.
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
K954710 · Northgate Technologies, Inc. · Apr 1996
ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
K955531 · Arthrocare Corp. · Feb 1996
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
K953453 · Symbiosis Corp. · Jan 1996
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