510(k) clearances

Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)

Mozarc Medical Us, LLC · Gastroenterology, Urology

K253469Substantially EquivalentTraditionalFIE
Open FDA's page for this record
Third party flag
N
City
Mansfield
Advisory committee description
Gastroenterology, Urology
Address 1
15 Hampshire St.
Statement or summary
Summary
Product code
FIE
Zip code
02048
Applicant
Mozarc Medical Us, LLC
Decision date
2026-08-06
Decision code
SESE
Country code
US
Advisory committee
GU
Contact
Sara Miller
K number
K253469
State
MA
Date received
2025-10-10
Review advisory committee
GU
Postal code
02048
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)

Harmonized identifiers (openFDA)
Device name
Needle, Fistula
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5540
Device class
2
Registration number
2029275, 3013217742, 3003464075, 3010273867, 3032143970, 3002807350, 3003895440, 2028632, 3010131137, 3000247873, 1056186, 9615908, 3010413216, 3013671177, 3010187826, 2032098, 8041145, 9616419
FEI number
3003464075, 1000132332, 3013217742, 3010273867, 3032143970, 3002807350, 1000306431, 3003895440, 3003058448, 3003656001, 1000125025, 3002974635, 3010131137, 3000247873, 3010413216, 3013671177, 3010187826, 3003282181
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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.