Nouvo Safety Set— 510(k) K232234
Substantially EquivalentPoly Medicure Limited
FDA 510(k) clearance K232234 for Nouvo Safety Set, Substantially Equivalent on 2024-03-15. Applicant: Poly Medicure Limited. Device class: 2.
Clearance details
- Applicant
- Poly Medicure Limited
- Product code
- Product code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Faridabad, IN
Recent devices under product code FOZ
view allMore clearances from Poly Medicure Limited
view all- K261670 — Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ) +5 more
- K252513 — Polywin Safety (14G x 51mm +17 more
- K252677 — Polyshield Safety IV Catheters
- K231401 — Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
- K230616 — Polyguard and Polyshield Safety IV Catheters
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.