Medical Device Manufacturer · US , Tempe , AZ

Medi-Globe Corporation - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2006

Recent clearances: EasyPass Guidewire, PolyCatch Retrieval Device, SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Medi-Globe Corporation Gastroenterology & Urology ✕

7 devices
1-7 of 7
Cleared May 19, 2016
EasyPass Guidewire
K153264 · OCY
Gastroenterology & Urology · 189d
Cleared Sep 30, 2014
PolyCatch Retrieval Device
K142258 · FDI
Gastroenterology & Urology · 47d
Cleared May 15, 2014
SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
K133763 · FCG
Gastroenterology & Urology · 155d
Cleared May 08, 2009
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
K091257 · FCG
Gastroenterology & Urology · 9d
Cleared Mar 20, 2009
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND...
K083802 · FCG
Gastroenterology & Urology · 88d
Cleared Jan 31, 2007
SONOTIP II ULTRASOUND NEEDLE SYSTEM
K070129 · FCG
Gastroenterology & Urology · 15d
Cleared Jun 27, 2006
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
K061684 · KNS
Gastroenterology & Urology · 12d
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