Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more— 510(k) K253469
Substantially EquivalentMozarc Medical Us, LLC
FDA 510(k) clearance K253469 for Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more, Substantially Equivalent on 2026-08-06. Applicant: Mozarc Medical Us, LLC. Device class: 2.
Summary
Mozarc Medical US's submission lists six Ritus Safety Fistula Cannula with Anti-Reflux Valve sizes, from 15G x 30mm (1530VSMM) to 17G x 38mm (1738VSMM). The product code is FIE, fistula needles.
Class II, 21 CFR 876.5540. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Mozarc filed from Mansfield, Massachusetts. Review took 300 calendar days (October 10, 2025 to August 6, 2026) and ended in a substantially equivalent decision.
Clearance details
- Device name as filed
- 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)
- Applicant
- Mozarc Medical Us, LLC
- Product code
- Product code FIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code FIE
view all- K251877 — JMS CAVEO A.V. Fistula Needle Set
- K213015 — DORA Disposable A.V. Fistula Needle Sets
- K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
- K163025 — DORA Disposable A.V. Fistula Needle Sets
- K151017 — JMS Harmony A.V. Fistula Needle Set
Adverse events under product code FIE
product code FIE- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.