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FDA 510(k)

XCelliStem Wound Powder

K-Number: K172593 · 2018-03-16

ApplicantStemsys
Decision Date2018-03-16
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

XCelliStem Wound Powder is a medical device manufactured by Stemsys. It received FDA 510(k) clearance on 2018-03-16 under approval number K172593. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XCelliStem Wound Powder?

XCelliStem Wound Powder is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by Stemsys. The 510(k) number is K172593.

When was XCelliStem Wound Powder approved by the FDA?

XCelliStem Wound Powder received FDA 510(k) clearance on 2018-03-16, under approval number K172593.

What company makes XCelliStem Wound Powder?

XCelliStem Wound Powder is manufactured by Stemsys.

What is the FDA product code for XCelliStem Wound Powder?

The FDA product code for XCelliStem Wound Powder is KGN.

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma AG

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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