Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva— 510(k) K231401

Name: FDA 510(k) clearance K231401
Creator: U.S. Food and Drug Administration
Published: 2023-09-21

Substantially Equivalent

Poly Medicure Limited

FDA 510(k) clearance K231401 for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva, Substantially Equivalent on 2023-09-21. Applicant: Poly Medicure Limited. Device class: 2.

Clearance details

Applicant: Poly Medicure Limited
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2023-05-15
Decision date: 2023-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Faridabad, IN

Download summary PDF View on FDA.gov ↗

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K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

More clearances from Poly Medicure Limited

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K252513 — Polywin Safety (14G x 51mm +17 more2026-04-01
K252677 — Polyshield Safety IV Catheters2025-11-05
K232234 — Nouvo Safety Set2024-03-15
K230616 — Polyguard and Polyshield Safety IV Catheters2023-05-05
K220312 — Polyfusion IV Administration Sets2023-04-12

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, 2020-01-01 through 2026-04-23. 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.