Cleared Traditional

K954536 - BLADE

K954536 is an FDA 510(k) clearance for BLADE, manufactured by Access Surgical Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCZ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K954536 · Access Surgical Intl., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
61d
Days
Class 2
Risk

K954536 is an FDA 510(k) clearance for the BLADE, SCALPEL & BLADE, HANDEL. Classified as Endoscopic Grasping/cutting Instrument, Non-powered (product code OCZ), Class II - Special Controls.

Submitted by Access Surgical Intl., Inc. (Plymouth, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 61 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 Access Surgical Intl., Inc. devices

FDA 510(k) Submission Details - K954536

510(k) Number K954536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1995
Decision Date November 29, 1995
Days to Decision 61 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
69d faster than avg
Panel avg: 130d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCZ Device Classification - Class 2, Special Controls

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 39
Devices cleared under the same product code (OCZ) and FDA review panel - the closest regulatory comparables to K954536.
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
KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES
K950434 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
BIOPSY SCISSORS
K942030 · Surgical Technologies, Inc. · Jun 1994
BIOSPSY FORCEPS
K920762 · Symbiosis Corp. · Aug 1992