Cleared Traditional

K955063 - OLYMPUS BASKET GRASPERS (FDA 510(k) Clearance)

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

K955063 · Olympus America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
77d
Days
Class 2
Risk

K955063 is an FDA 510(k) clearance for the OLYMPUS BASKET GRASPERS. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: 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 Olympus America, Inc. devices

Submission Details

510(k) Number K955063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1995
Decision Date January 22, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCZ Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.
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.