FDA 510(k)

IODOSORB

K-Number: K190730 · 2019-12-20

Decision Date2019-12-20

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

IODOSORB is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K190730. 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 IODOSORB?

IODOSORB is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K190730.

When did IODOSORB receive FDA 510(k) clearance?

IODOSORB received FDA 510(k) clearance on 2019-12-20, under 510(k) number K190730.

Who is the listed applicant for IODOSORB?

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

What is the FDA product code for IODOSORB?

The FDA product code for IODOSORB is FRO. This falls under the Anesthesiology category.

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Official Source

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