Medical Device Manufacturer · US , Bonita Springs , FL

Crospon, Ltd. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2009

Recent clearances: EndoFLIP System, EsoFLIP® ES-310 Balloon Catheter, EndoFLIP® System with FLIP Topography module

12
Total
12
Cleared
0
Denied

FDA 510(k) Regulatory Record - Crospon, Ltd. Gastroenterology & Urology ✕

12 devices
1-12 of 12
Cleared Feb 15, 2019
EndoFLIP System
K183072 · FFX
Gastroenterology & Urology · 102d
Cleared Nov 22, 2017
EsoFLIP® ES-310 Balloon Catheter
K172128 · PIE
Gastroenterology & Urology · 131d
Cleared Apr 17, 2017
EndoFLIP® System with FLIP Topography module
K170833 · FFX
Gastroenterology & Urology · 28d
Cleared May 01, 2016
EndoFLIP
K160725 · FFX
Gastroenterology & Urology · 46d
Cleared Sep 25, 2014
ESOFLIP ES
K142000 · PIE
Gastroenterology & Urology · 64d
Cleared Oct 07, 2013
ESOFLIP BALLOON DILATION CATHETER
K132337 · PID
Gastroenterology & Urology · 73d
Cleared Jul 17, 2013
ENDOFLIP CATHETER
K130906 · FFX
Gastroenterology & Urology · 107d
Cleared Aug 27, 2012
BAROSTAT SOFTWARE OPTION
K120997 · FFX
Gastroenterology & Urology · 147d
Cleared Oct 06, 2011
ENDOFLIP ECD
K110531 · FED
Gastroenterology & Urology · 224d
Cleared Jul 22, 2011
ENDOFLIP GASTRIC TUBE
K110529 · KNT
Gastroenterology & Urology · 148d
Cleared Dec 16, 2010
ENDO FLIP
K102214 · FFX
Gastroenterology & Urology · 132d
Cleared Dec 15, 2009
ENDOFLIP
K092850 · FFX
Gastroenterology & Urology · 90d
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