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FDA 510(k)

KerraCel Ag Gelling Fiber Silver Dressing

K-Number: K162508 · 2017-02-13

ApplicantExciton Technologies, Inc.
Decision Date2017-02-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

KerraCel Ag Gelling Fiber Silver Dressing is a medical device manufactured by Exciton Technologies, Inc.. It received FDA 510(k) clearance on 2017-02-13 under approval number K162508. 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 KerraCel Ag Gelling Fiber Silver Dressing?

KerraCel Ag Gelling Fiber Silver Dressing is a medical device that received FDA 510(k) clearance on 2017-02-13. It is manufactured by Exciton Technologies, Inc.. The 510(k) number is K162508.

When was KerraCel Ag Gelling Fiber Silver Dressing approved by the FDA?

KerraCel Ag Gelling Fiber Silver Dressing received FDA 510(k) clearance on 2017-02-13, under approval number K162508.

What company makes KerraCel Ag Gelling Fiber Silver Dressing?

KerraCel Ag Gelling Fiber Silver Dressing is manufactured by Exciton Technologies, Inc..

What is the FDA product code for KerraCel Ag Gelling Fiber Silver Dressing?

The FDA product code for KerraCel Ag Gelling Fiber Silver Dressing 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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