510(k) K060805

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM by Given Imaging , Ltd. — Product Code NSI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 24, 2006
Date Received: March 24, 2006
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Imaging, Esophageal, Wireless, Capsule
Device Class: Class II
Regulation Number: 876.1300
Review Panel: GU
Submission Type

THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL.

Other clearances by Given Imaging , Ltd.

K180171 — PillCam Patency System (March 8, 2018)
K170210 — PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (September 1, 2017)
K170839 — RAPID Web (May 26, 2017)
K151086 — ManoScan System (April 28, 2016)
K153466 — PillCam COLON 2 Capsule Endoscopy System (January 14, 2016)
K140284 — GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM (December 17, 2014)
DEN120023 — GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (January 29, 2014)
K123864 — GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSC (August 12, 2013)
K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO (May 13, 2011)
K101250 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES (March 7, 2011)

Other clearances for product code NSI

K180171 — PillCam Patency System (March 8, 2018)
K090557 — GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATEN (September 28, 2009)
K071153 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE (June 11, 2007)
K052184 — GIVEN DIAGNOSTIC SYSTEM (December 1, 2005)
K042960 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO (November 24, 2004)
K041149 — GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE (October 25, 2004)