Cleared Special

K002802 - RAPID EXCHANGE TAPERTOME

K002802 is an FDA 510(k) clearance for RAPID EXCHANGE TAPERTOME, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Special 510(k) pathway after a 27-day FDA review.

K002802 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
27d
Days
Class 2
Risk

K002802 is an FDA 510(k) clearance for the RAPID EXCHANGE TAPERTOME. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on October 5, 2000 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002802

510(k) Number K002802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2000
Decision Date October 05, 2000
Days to Decision 27 days
Submission Type Special
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
104d faster than avg
Panel avg: 131d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 182
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K002802.
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
K002583 · Vidamed, Inc. · Feb 2001
HORIZONS PAPILLOTOME
K002236 · Horizons Intl. Corp. · Jan 2001
PLASMAKINETIC ENDOUROLOGY SYSTEM
K003569 · Gyrus Medical , Ltd. · Dec 2000
THERMOFLEX SYSTEM
K000508 · Argomed, Inc. · Apr 2000
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
K994166 · Gyrus Medical , Ltd. · Dec 1999
5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
K992402 · Telemed Systems, Inc. · Dec 1999
K002802 · RAPID EXCHANGE TAPERTOME
Download PDF FDA Summary Boston Scientific Corp