Cleared Traditional

K961611 - OLYMPUS BASKET GRASPERS (UROLOGY)

K961611 is the FDA 510(k) clearance for OLYMPUS BASKET GRASPERS (UROLOGY) by Olympus America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCZ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K961611 · Olympus America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
84d
Days
Class 2
Risk

K961611 is an FDA 510(k) clearance for the OLYMPUS BASKET GRASPERS (UROLOGY). 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 July 18, 1996 after a review of 84 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 K961611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1996
Decision Date July 18, 1996
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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.

Regulatory Peers - OCZ Endoscopic Grasping/cutting Instrument, Non-powered

All 36
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K961611.
ENDOSCOPIC RETRIEVAL DEVICE
K120084 · United States Endoscopy Group, Inc. · May 2012
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · Richard Wolf Medical Instruments Corp. · Oct 2005
STONE EXTRACTOR
K971123 · Phx Technologies Corp. · Jun 1997
OLYMPUS FG SERIES GRASPING FORCEPS
K955066 · Olympus America, Inc. · Jan 1996
OLYMPUS BASKET GRASPERS
K955063 · Olympus America, Inc. · Jan 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS
K955051 · Olympus America, Inc. · Jan 1996