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510(k) K153466

PillCam COLON 2 Capsule Endoscopy System by Given Imaging , Ltd. — Product Code PGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2016
Date Received
December 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colon Capsule Imaging System
Device Class
Class II
Regulation Number
876.1330
Review Panel
GU
Submission Type

visualization of the colon for the detection of polyps

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)
  • 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 PGD

  • DEN120023 — GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (January 29, 2014)