510(k) K240057
K240057 is an FDA 510(k) premarket notification submitted by Sentinel Medical Technologies, LLC for the device "TraumaGuard Intra-abdominal Pressure Sensing System". The FDA issued a decision of Substantially Equivalent on April 17, 2024. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Sentinel Medical Technologies, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2024
- Date Received
- January 8, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type