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FDA 510(k)

TorrentX Wound Wash

K-Number: K203446 · 2021-09-23

Decision Date2021-09-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TorrentX Wound Wash is a medical device manufactured by Next Science, LLC. It received FDA 510(k) clearance on 2021-09-23 under approval number K203446. 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 TorrentX Wound Wash?

TorrentX Wound Wash is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Next Science, LLC. The 510(k) number is K203446.

When was TorrentX Wound Wash approved by the FDA?

TorrentX Wound Wash received FDA 510(k) clearance on 2021-09-23, under approval number K203446.

What company makes TorrentX Wound Wash?

TorrentX Wound Wash is manufactured by Next Science, LLC.

What is the FDA product code for TorrentX Wound Wash?

The FDA product code for TorrentX Wound Wash is FRO. This falls under the Anesthesiology category.

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Official Source

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