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FDA 510(k)

Celox Rapid X-Ray Gauze

K-Number: K230589 · 2023-11-17

Decision Date2023-11-17
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Celox Rapid X-Ray Gauze is the device name listed in this FDA 510(k) record. The listed applicant is Medtrade Products , Ltd.. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K230589. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celox Rapid X-Ray Gauze?

Celox Rapid X-Ray Gauze is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Medtrade Products , Ltd.. The 510(k) number is K230589.

When did Celox Rapid X-Ray Gauze receive FDA 510(k) clearance?

Celox Rapid X-Ray Gauze received FDA 510(k) clearance on 2023-11-17, under 510(k) number K230589.

Who is the listed applicant for Celox Rapid X-Ray Gauze?

The FDA 510(k) record lists Medtrade Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Celox Rapid X-Ray Gauze?

The FDA product code for Celox Rapid X-Ray Gauze is QSY.

Other records listing Medtrade Products , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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