FDA 510(k)

抗生物質ガーゼスポンジ包帯；抗生物質スーパースポンジ包帯；抗生物質非織布スポンジ包帯

K番号: K221755 · 2023-01-13

決定日2023-01-13

製品コードFRO

決定大幅同等

医療機器の概要

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing is the device name listed in this FDA 510(k) record. The listed applicant is Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221755. 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 Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing?

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Winner Medical Co., Ltd.. The 510(k) number is K221755.

When did Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing receive FDA 510(k) clearance?

Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221755.

Who is the listed applicant for Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing?

The FDA 510(k) record lists Winner Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing?

The FDA product code for Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing is FRO. This falls under the Anesthesiology category.