FDA 510(k)

PluroGel® 抗菌燒傷和創傷敷料，PluroGel® 燒傷和創傷敷料（OTC）

K 號：K233151 · 2024-03-26

決定日期2024-03-26

產品代碼FRO

決定相當於

器材摘要

PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2024-03-26 under 510(k) number K233151. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)?

PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) is a medical device that received FDA 510(k) clearance on 2024-03-26. The listed applicant is Medline Industries, LP. The 510(k) number is K233151.

When did PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) receive FDA 510(k) clearance?

PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) received FDA 510(k) clearance on 2024-03-26, under 510(k) number K233151.

Who is the listed applicant for PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)?

FDA 510(k) 記錄中將 Medline Industries, LP 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)?

The FDA product code for PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) is FRO. This falls under the Anesthesiology category.