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510(k) K180171

PillCam Patency System by Given Imaging , Ltd. — Product Code NSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2018
Date Received
January 22, 2018
Clearance Type
Traditional
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.

  • 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)
  • K103088 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT (January 14, 2011)

Other clearances for product code NSI

  • 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)
  • K060805 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (May 24, 2006)
  • 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)