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510(k) K170210

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 by Given Imaging , Ltd. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2017
Date Received
January 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • 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)

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