510(k) clearances

TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)

Sentinel Medical Technologies, · Gastroenterology, Urology

K260756Substantially EquivalentTraditionalEZL
Open FDA's page for this record
Third party flag
N
City
Jacksonville
Advisory committee description
Gastroenterology, Urology
Address 1
50 N Laura St.
Address 2
Suite 2500
Statement or summary
Summary
Product code
EZL
Zip code
32202
Applicant
Sentinel Medical Technologies,
Decision date
2026-09-04
Decision code
SESE
Country code
US
Device name
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)
Advisory committee
GU
Contact
Jackelyn Rodriguez
K number
K260756
State
FL
Date received
2026-03-09
Review advisory committee
GU
Postal code
32202
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Catheter, Retention Type, Balloon
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5130
Device class
2
Registration number
3022516937, 3004070478, 1417592, 8030107, 3005609751, 3012050423, 9612030, 8022978, 3015142802, 1314417, 3010220595, 3006787036, 3004111573, 3005669815, 1820334, 3031190571, 3005515211, 1058397, 3011252788, 3009086335, 3005012805, 3030446844, 3014650073, 3005483737, 1018233, 3011383638, 3005941719, 3020978007, 9616088, 8041005, 3008496528, 3011137372, 1649518, 3010314836, 3016618143, 3014766734, 3013369910, 3013002100, 2320762, 1061124 +80 more
FEI number
3022516937, 3004070478, 1417592, 7682, 3005609751, 3012050423, 3015142802, 1314417, 3010220595, 3006787036, 3004111573, 3005669815, 1820334, 3031190571, 3005515211, 3009271244, 3016261803, 3002806934, 3011252788, 3009086335, 3005012805, 1000112877, 1000160458, 3001236277, 3030446844, 3014650073, 1000512168, 3005483737, 1018233, 1000521377, 3011383638, 3000215273, 3020978007, 3008496528, 3010314836, 3016618143, 3014766734, 3013369910, 3013002100, 3027301746 +80 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.