Cleared Traditional

K000508 - THERMOFLEX SYSTEM

K000508 is an FDA 510(k) clearance for THERMOFLEX SYSTEM, manufactured by Argomed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K000508 · Argomed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
63d
Days
Class 2
Risk

K000508 is an FDA 510(k) clearance for the THERMOFLEX SYSTEM. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Argomed, Inc. (Morrisville, US). The FDA issued a Cleared decision on April 18, 2000 after a review of 63 days - a notably fast clearance cycle.

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: 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 Argomed, Inc. devices

FDA 510(k) Submission Details - K000508

510(k) Number K000508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2000
Decision Date April 18, 2000
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNS Device Classification - Class 2, Special Controls

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 116
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K000508.
AUTOTOME RX MODEL # 4515, 4516
K013153 · Boston Scientific Corp · Oct 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · Arthrocare Corp. · Mar 2001
RAPID EXCHANGE TAPERTOME
K002802 · Boston Scientific Corp · Oct 2000
COOPERSURGICAL INFRARED COAGULATOR
K990852 · CooperSurgical, Inc. · Jun 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
K990850 · CooperSurgical, Inc. · Jun 1999
COOPERSURGICAL INFRARED COAGULATOR FOR ENT
K990855 · CooperSurgical, Inc. · Mar 1999