Home / 510(k) Clearances / K112106

510(k) K112106

NAVIAID ICVI-F,S,B,R DEVICE by Smart Medical Systems , Ltd. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2012
Date Received
July 22, 2011
Clearance Type
Traditional
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.

Other clearances by Smart Medical Systems , Ltd.

  • K220158 — G-EYE System (April 11, 2022)
  • K202469 — G-EYE System (October 26, 2020)
  • K192588 — G-EYE System (April 15, 2020)
  • K111760 — NAVIAID(TM) BGC DEVICE (August 9, 2011)
  • 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)

Other clearances for product code ODC

  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)
  • K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Si (March 22, 2024)