FDA 510(k)

PluroGel® 抗菌性ブーンおよびウルドドレッシング、PluroGel® ブーンおよびウルドドレッシング（OTC）

K番号: K233151 · 2024-03-26

決定日2024-03-26

製品コードFRO

決定大幅同等

医療機器の概要

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.

よくある質問

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)レコードには、Medline Industries, LPが申請者として記載されています。これ自体で装置製造業者であることを確立するものではありません。

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.