Cleared Traditional

K102214 - ENDO FLIP

K102214 is an FDA 510(k) clearance for ENDO FLIP, manufactured by Crospon, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K102214 · Crospon, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
132d
Days
Class 2
Risk

K102214 is an FDA 510(k) clearance for the ENDO FLIP. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Crospon, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on December 16, 2010 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K102214

510(k) Number K102214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2010
Decision Date December 16, 2010
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 131d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FFX System, Gastrointestinal Motility (electrical)

All 69
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K102214.
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K120524 · Mui Scientific · Jun 2012
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K102801 · E-Cath Co., Ltd. · Oct 2010
ENDOFLIP
K092850 · Crospon, Ltd. · Dec 2009
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
K091070 · Sierra Scientific Instruments, Inc. · May 2009
K102214 · ENDO FLIP
Download PDF FDA Summary Crospon, Ltd.