Cleared Special

K231533 - Habib EndoHPB

K231533 is an FDA 510(k) clearance for Habib EndoHPB, 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 26-day FDA review.

K231533 · Boston Scientific Corporation · Gastroenterology & Urology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Jun 2023

Decision

26d

Days

Class 2

Risk

K231533 is an FDA 510(k) clearance for the Habib EndoHPB. 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 June 21, 2023 after a review of 26 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 - K231533

510(k) Number	K231533 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 26, 2023
Decision Date	June 21, 2023
Days to Decision	26 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

105d faster than avg

Panel avg: 131d · This submission: 26d

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

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FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.