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510(k) K220158

G-EYE System by Smart Medical Systems , Ltd. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2022
Date Received
January 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Smart Medical Systems , Ltd.

  • K202469 — G-EYE System (October 26, 2020)
  • K192588 — G-EYE System (April 15, 2020)
  • K112106 — NAVIAID ICVI-F,S,B,R DEVICE (February 6, 2012)
  • 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 FDF

  • K252457 — Disposable Distal End Tape Hood (January 30, 2026)
  • K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (September 24, 2025)
  • K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM (May 23, 2025)
  • K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal (May 15, 2025)
  • K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL) (January 3, 2025)
  • K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (October 4, 2024)
  • K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
  • K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
  • K232922 — Pure-Vu EVS System (October 20, 2023)
  • K230332 — Ambu® aScope™ Colon; Ambu® aBox™ 2 (September 15, 2023)