Cleared Special

K170833 - EndoFLIP® System with FLIP Topography module

K170833 is an FDA 510(k) clearance for EndoFLIP System with FLIP Topography module, manufactured by Crospon, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Special 510(k) pathway after a 28-day FDA review.

K170833 · Crospon, Ltd. · Gastroenterology & Urology device
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Apr 2017
Decision
28d
Days
Class 2
Risk

K170833 is an FDA 510(k) clearance for the EndoFLIP® System with FLIP Topography module. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Crospon, Ltd. (Galway, IE). The FDA issued a Cleared decision on April 17, 2017 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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 Crospon, Ltd. devices

FDA 510(k) Submission Details - K170833

510(k) Number K170833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2017
Decision Date April 17, 2017
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FFX Device Classification - Class 2, Special Controls

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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

Crospon Ltd., C/O Promedic, LLC
Paul Dryden

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 - FFX System, Gastrointestinal Motility (electrical)

All 43
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K170833.
Transit-Pellets
K181760 · Medifactia AB · Aug 2019
EndoFLIP System
K183072 · Crospon, Ltd. · Feb 2019
SITZMARKS
K181750 · Konsyl Pharmaceuticals · Nov 2018
Rapid Barostat Bag (RBB) Pump and Catheter
K160287 · Mui Scientific · Mar 2017
Lehman Manometry Catheter
K160170 · Wilson-Cook Medical, Inc. · Jun 2016
EndoFLIP
K160725 · Crospon, Ltd. · May 2016