FDA 510(k)

Saline Wound Wash, SteriCleanse(TM)

Número K: K183662 · 2019-09-12

RequerenteAscent Consumer Products, Inc.

Data da decisão2019-09-12

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Saline Wound Wash, SteriCleanse(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Consumer Products, Inc.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K183662. 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.

Perguntas frequentes

What is the Saline Wound Wash, SteriCleanse(TM)?

Saline Wound Wash, SteriCleanse(TM) is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Ascent Consumer Products, Inc.. The 510(k) number is K183662.

When did Saline Wound Wash, SteriCleanse(TM) receive FDA 510(k) clearance?

Saline Wound Wash, SteriCleanse(TM) received FDA 510(k) clearance on 2019-09-12, under 510(k) number K183662.

Who is the listed applicant for Saline Wound Wash, SteriCleanse(TM)?

The FDA 510(k) record lists Ascent Consumer Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Saline Wound Wash, SteriCleanse(TM)?

The FDA product code for Saline Wound Wash, SteriCleanse(TM) is FRO. This falls under the Anesthesiology category.

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