Cleared Special

K133933 - INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

K133933 is an FDA 510(k) clearance for INJECTION GOLD PROBE BIPOLAR ELECTROHEM..., manufactured by Boston Scientific Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Special 510(k) pathway after a 100-day FDA review.

K133933 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
100d
Days
Class 2
Risk

K133933 is an FDA 510(k) clearance for the INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on April 2, 2014 after a review of 100 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. 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. Standard predicate reliance. 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 - K133933

510(k) Number K133933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date April 02, 2014
Days to Decision 100 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
31d faster than avg
Panel avg: 131d · This submission: 100d
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 188
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K133933 · INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
Download PDF FDA Summary Boston Scientific Cor…