BONREE Nelaton Catheter— 510(k) K212430

Name: FDA 510(k) clearance K212430
Creator: U.S. Food and Drug Administration
Published: 2022-04-29

Substantially Equivalent

Bonree Medical Co., Ltd.

FDA 510(k) clearance K212430 for BONREE Nelaton Catheter, Substantially Equivalent on 2022-04-29. Applicant: Bonree Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bonree Medical Co., Ltd.
Product code: Code EZD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2021-08-04
Decision date: 2022-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhongshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZD

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K260737 — Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16) +2 more2026-08-05
K261658 — LoFric Origo Pro Coudé2026-07-17
K262045 — Luja Soft2026-07-07
K260394 — Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)2026-06-24
K253295 — Coude Sleeved IC; Coude Plus Sleeved IC2026-05-18

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.