VS-370CF, VS-370CT— 510(k) K262152
Substantially EquivalentVISION MEDICAL Co., Ltd.
FDA 510(k) clearance K262152 for VS-370CF, VS-370CT, Substantially Equivalent on 2026-07-24. Applicant: VISION MEDICAL Co., Ltd.. Device class: 2.
Summary
VISION MEDICAL's VS-370CF and VS-370CT are filed under FCX, automatic carbon dioxide insufflators for endoscopes. The names are model designations, and the record doesn't say how the two differ.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
VISION MEDICAL filed from Incheon, South Korea. Review took 29 calendar days (June 25 to July 24, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- VISION MEDICAL Co., Ltd.
- Product code
- Product code FCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Incheon, KR
Recent devices under product code FCX
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