NEZ · Class II · 21 CFR 876.1300

FDA Product Code NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

Leading manufacturers include Given Imaging , Ltd., Intromedic Co., Ltd. and CapsoVision, Inc..

47
Total
46
Cleared
149d
Avg days
2001
Since
47 devices
25–47 of 47
Cleared Jun 30, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K140751
Intromedic Co., Ltd.
Gastroenterology & Urology · 97d
Cleared Aug 12, 2013
GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
K123864
Given Imaging , Ltd.
Gastroenterology & Urology · 238d
Cleared May 20, 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K123428
Intromedic Co., Ltd.
Gastroenterology & Urology · 194d
Cleared Apr 29, 2013
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K123421
Olympus Medical Systems Corp.
Gastroenterology & Urology · 174d
Cleared May 18, 2012
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K111450
Intromedic Co., Ltd.
Gastroenterology & Urology · 359d
Cleared May 13, 2011
GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
K103025
Given Imaging , Ltd.
Gastroenterology & Urology · 213d
Cleared Mar 07, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
K101250
Given Imaging , Ltd.
Gastroenterology & Urology · 307d
Cleared Jan 14, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
K103088
Given Imaging , Ltd.
Gastroenterology & Urology · 87d
Cleared Sep 30, 2010
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
K101200
Given Imaging , Ltd.
Gastroenterology & Urology · 154d
Cleared Jul 29, 2009
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210
Olympus Medical Systems Corporation
Gastroenterology & Urology · 182d
Cleared Jul 29, 2009
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
K091405
Given Imaging , Ltd.
Gastroenterology & Urology · 78d
Cleared Sep 14, 2007
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K063259
Olympus Medical Systems Corporation
Gastroenterology & Urology · 319d
Cleared May 07, 2007
MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
K070475
Given Imaging , Ltd.
Gastroenterology & Urology · 76d
Cleared Oct 18, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K062786
Given Imaging , Ltd.
Gastroenterology & Urology · 30d
Cleared May 08, 2006
GIVEN DIAGNOSTIC SYSTEM
K053639
Given Imaging , Ltd.
Gastroenterology & Urology · 129d
Cleared Jun 23, 2004
CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143
K040494
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 118d
Cleared Feb 17, 2004
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K040248
Given Imaging , Ltd.
Gastroenterology & Urology · 14d
Cleared Oct 29, 2003
GIVEN DIAGNOSTIC SYSTEM
K032405
Given Imaging , Ltd.
Gastroenterology & Urology · 86d
Cleared Jul 01, 2003
GIVEN DIAGNOSTIC SYSTEM
K031033
Given Imaging , Ltd.
Gastroenterology & Urology · 91d
Cleared Feb 27, 2003
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K022980
Given Imaging , Ltd.
Gastroenterology & Urology · 171d
Cleared Aug 09, 2002
GIVEN DIAGNOSTICS SYSTEM
K022362
Given Imaging , Ltd.
Gastroenterology & Urology · 18d
Cleared May 02, 2002
GIVEN DIAGNOSTIC SYSTEM
K020341
Given Imaging , Ltd.
Gastroenterology & Urology · 90d
Not Cleared Aug 01, 2001
GIVEN DIAGNOSTIC IMAGING SYSTEM
DEN010002
Given Imaging , Ltd.
Gastroenterology & Urology · 51d