VS-370CF, VS-370CT
FDA 510(k) clearance K262152 · decided 2026-07-24
Clearance details
- K-number
- K262152
- Device name
- VS-370CF, VS-370CT
- Applicant
- VISION MEDICAL Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-06-25
- Decision date
- 2026-07-24
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- FCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Incheon, KR
- Third-party review
- Yes
- Expedited review
- No
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| BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (K123047) | Bracco Diagnostic, Inc. | 2013-08-06 |
| ENDOGATER AVANTAGE CO2 INSUFFLATOR (K113310) | Byrne Medical, Inc. | 2012-06-20 |
| BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR (K111648) | Bracco Diagnostic, Inc. | 2011-11-03 |
Recalls involving this device
No recalls on record reference this clearance.