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FDA 510(k)

AMSure® Single Use Saline Topical Solution

K-Number: K201138 · 2021-04-14

ApplicantAmsino Medical, Inc.
Decision Date2021-04-14
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

AMSure® Single Use Saline Topical Solution is a medical device manufactured by Amsino Medical, Inc.. It received FDA 510(k) clearance on 2021-04-14 under approval number K201138. 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 AMSure® Single Use Saline Topical Solution?

AMSure® Single Use Saline Topical Solution is a medical device that received FDA 510(k) clearance on 2021-04-14. It is manufactured by Amsino Medical, Inc.. The 510(k) number is K201138.

When was AMSure® Single Use Saline Topical Solution approved by the FDA?

AMSure® Single Use Saline Topical Solution received FDA 510(k) clearance on 2021-04-14, under approval number K201138.

What company makes AMSure® Single Use Saline Topical Solution?

AMSure® Single Use Saline Topical Solution is manufactured by Amsino Medical, Inc..

What is the FDA product code for AMSure® Single Use Saline Topical Solution?

The FDA product code for AMSure® Single Use Saline Topical Solution is FRO. This falls under the Anesthesiology category.

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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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