Cleared Special

K160417 - Rezum System

K160417 is an FDA 510(k) clearance for Rezum System, manufactured by Nxthera, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNS cleared through the Special 510(k) pathway after a 30-day FDA review.

K160417 · Nxthera, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
30d
Days
Class 2
Risk

K160417 is an FDA 510(k) clearance for the Rezum System. Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (product code KNS), Class II - Special Controls.

Submitted by Nxthera, Inc. (Maple Grove, US). The FDA issued a Cleared decision on March 17, 2016 after a review of 30 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.

View all Nxthera, Inc. devices

FDA 510(k) Submission Details - K160417

510(k) Number K160417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date March 17, 2016
Days to Decision 30 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
101d faster than avg
Panel avg: 131d · This submission: 30d
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 Consultant

Libramedical, Inc.
Julie Bodmer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

All 167
Devices cleared under the same product code (KNS) and FDA review panel - the closest regulatory comparables to K160417.
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
K171983 · Creo Medical, Ltd. · Aug 2017
Zimmon Needle Knife Papillotome
K171993 · Wilson-Cook Medical Inc./Cook Endoscopy · Aug 2017
SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
K152771 · Sumitomo Bakelite Co., Ltd. · Jun 2016
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
K160241 · Olympus Medical Systems Corp. · Mar 2016
Single Use Balloon Dilator V (with Knife)
K150142 · Olympus Medical Systems Corp. · Oct 2015
Rezum System
K150786 · Nxthera, Inc. · Aug 2015