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510(k) K111760

NAVIAID(TM) BGC DEVICE by Smart Medical Systems , Ltd. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2011
Date Received
June 22, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

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  • K110291 — NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE (June 17, 2011)
  • K102616 — NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE (December 30, 2010)
  • K101191 — NAVIAID ICVI DEVICE (July 27, 2010)
  • K060923 — NAVIAID BGE DEVICE, MODEL 21-001 (August 15, 2006)

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