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510(k) K262152

VS-370CF, VS-370CT by VISION MEDICAL Co., Ltd. — Product Code FCX

K262152 is an FDA 510(k) premarket notification submitted by VISION MEDICAL Co., Ltd. for the device "VS-370CF, VS-370CT". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2026
Date Received
June 25, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances for product code FCX

  • K240847 — MedicCO2LON (MedicCO2LON) (October 30, 2024)
  • K230474 — EVA5 Insufflator (March 24, 2023)
  • K202922 — END 200 Endoscopic Tubeset (July 8, 2021)
  • K201096 — CO2mbiLED (June 23, 2020)
  • K190985 — BAROnova Insufflation System, BAROnova Accessory Kit (May 14, 2019)
  • K180711 — FUJIFILM Endoscopic CO2 Regulator GW-100 (May 25, 2018)
  • K162332 — Nexcore GI Insufflator (September 29, 2016)
  • K133976 — FUJIFILM ENDOSCOPIC CO2 REGULATOR (September 9, 2014)
  • K132192 — BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR (February 14, 2014)
  • K123047 — BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (August 6, 2013)

FDA data resources