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510(k) K071153

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE by Given Imaging , Ltd. — Product Code NSI

K071153 is an FDA 510(k) premarket notification submitted by Given Imaging , Ltd. for the device "GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE". The FDA issued a decision of Substantially Equivalent on June 11, 2007. The device falls under product code NSI (System, Imaging, Esophageal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Given Imaging , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2007
Date Received
April 25, 2007
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)
  • 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)

FDA data resources