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FDA 510(k)

SURECELL Gelling Fiber Wound Dressing

K-Number: K173005 · 2018-05-25

ApplicantJiangsu Newvalue Medical Producst Co.,Ltd
Decision Date2018-05-25
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

SURECELL Gelling Fiber Wound Dressing is a medical device manufactured by Jiangsu Newvalue Medical Producst Co.,Ltd. It received FDA 510(k) clearance on 2018-05-25 under approval number K173005. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURECELL Gelling Fiber Wound Dressing?

SURECELL Gelling Fiber Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-05-25. It is manufactured by Jiangsu Newvalue Medical Producst Co.,Ltd. The 510(k) number is K173005.

When was SURECELL Gelling Fiber Wound Dressing approved by the FDA?

SURECELL Gelling Fiber Wound Dressing received FDA 510(k) clearance on 2018-05-25, under approval number K173005.

What company makes SURECELL Gelling Fiber Wound Dressing?

SURECELL Gelling Fiber Wound Dressing is manufactured by Jiangsu Newvalue Medical Producst Co.,Ltd.

What is the FDA product code for SURECELL Gelling Fiber Wound Dressing?

The FDA product code for SURECELL Gelling Fiber Wound Dressing is KGN.

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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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