510(k) K060923

NAVIAID BGE DEVICE, MODEL 21-001 by Smart Medical Systems , Ltd. — Product Code FDA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 15, 2006
Date Received: April 4, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Enteroscope And Accessories
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To provide visualization and perform various procedures within the small intestine. 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.

K220158 — G-EYE System (April 11, 2022)
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)

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K231323 — Ancora-SB (August 31, 2023)
K223295 — Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D (January 11, 2023)
K213195 — Balloon BS-3 (October 29, 2021)
K191330 — Arc Enterocuff (January 31, 2020)
K183032 — FUJIFILM Double Balloon Endoscope EI580BT (June 24, 2019)
K183683 — FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 (February 27, 2019)
K143556 — Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T (August 20, 2015)
K071254 — SMALL INTESTINAL VIDEOSCOPE SYSTEM (March 25, 2008)