Promisemed Safety Huber Needles— 510(k) K251138

Name: FDA 510(k) clearance K251138
Creator: U.S. Food and Drug Administration
Published: 2025-05-13

Substantially Equivalent

Promisemed Hangzhou Meditech Co., Ltd.

FDA 510(k) clearance K251138 for Promisemed Safety Huber Needles, Substantially Equivalent on 2025-05-13. Applicant: Promisemed Hangzhou Meditech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Promisemed Hangzhou Meditech Co., Ltd.
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2025-04-14
Decision date: 2025-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Hangzhou City, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.