510(k) clearance
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
- 510(k) number
- K260756
- Applicant
- Sentinel Medical Technologies,
- Decision date
- Sep 4, 2026
- Date received
- Mar 9, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EZL
- Device type
- Catheter, Retention Type, Balloon
- Device class
- Class II
- Regulation
- 21 CFR 876.5130
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Jacksonville, FL, US