Cleared Traditional

K992402 - 5.0 FRENCH X 200CM X 35MM TIP TAPER-20M...

K992402 is an FDA 510(k) clearance for 5.0 FRENCH X 200CM X 35MM TIP TAPER-20M..., manufactured by Telemed Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K992402 · Telemed Systems, Inc. · Gastroenterology & Urology device
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Dec 1999
Decision
156d
Days
Class 2
Risk

K992402 is an FDA 510(k) clearance for the 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 3.... Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Telemed Systems, Inc. (Marlborough, US). The FDA issued a Cleared decision on December 22, 1999 after a review of 156 days - an extended review 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: 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 Telemed Systems, Inc. devices

FDA 510(k) Submission Details - K992402

510(k) Number K992402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1999
Decision Date December 22, 1999
Days to Decision 156 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
26d slower than avg
Panel avg: 130d · This submission: 156d
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 128
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K992402.
AUTOTOME RX MODEL # 4515, 4516
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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
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME
K990376 · Ballard Medical Products · May 1999