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FDA 510(k)

Saline Wound Wash, SteriCleanse(TM)

K-Number: K183662 · 2019-09-12

ApplicantAscent Consumer Products, Inc.
Decision Date2019-09-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Saline Wound Wash, SteriCleanse(TM) is a medical device manufactured by Ascent Consumer Products, Inc.. It received FDA 510(k) clearance on 2019-09-12 under approval 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.

Frequently Asked Questions

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. It is manufactured by Ascent Consumer Products, Inc.. The 510(k) number is K183662.

When was Saline Wound Wash, SteriCleanse(TM) approved by the FDA?

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

What company makes Saline Wound Wash, SteriCleanse(TM)?

Saline Wound Wash, SteriCleanse(TM) is manufactured by Ascent Consumer Products, Inc..

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.

Related Clinical Trials

NCT07321704 Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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