Cleared Traditional

K945764 - HIGH TEMPERATURE CAUTERY ELONGATED FINE...

K945764 is the FDA 510(k) clearance for HIGH TEMPERATURE CAUTERY ELONGATED FINE... by Aaron Medical Industries. It is a Class 2 Gastroenterology & Urology device (product code KNS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K945764 · Aaron Medical Industries · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
90d
Days
Class 2
Risk

K945764 is an FDA 510(k) clearance for the HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 90 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 Aaron Medical Industries devices

Submission Details

510(k) Number K945764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1994
Decision Date January 30, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
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 - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 115
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K945764.
OLYMPUS KD SERIES SPHINCTEROTOME
K955247 · Olympus America, Inc. · Apr 1996
CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS
K946109 · Cabot Medical Corp. · Nov 1995
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE
K950166 · Olympus America, Inc. · Feb 1995
AESCULAP THORACOSCOPIC INSTRUMENTS
K944955 · Aesculap, Inc. · Nov 1994
MICROVASIVE INJECTION GOLD PROBE
K942301 · Boston Scientific Corp · Nov 1994
CABOT MEDICAL BIPOLAR CUTTING FORCEPS
K932293 · Cabot Medical Corp. · Jul 1994