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FDA 510(k)

SupraSDRM Biodegradable Matrix Wound Dressing

K-Number: K170213 · 2017-06-28

ApplicantPolymedics Innovations, GmbH
Decision Date2017-06-28
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

SupraSDRM Biodegradable Matrix Wound Dressing is a medical device manufactured by Polymedics Innovations, GmbH. It received FDA 510(k) clearance on 2017-06-28 under approval number K170213. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SupraSDRM Biodegradable Matrix Wound Dressing?

SupraSDRM Biodegradable Matrix Wound Dressing is a medical device that received FDA 510(k) clearance on 2017-06-28. It is manufactured by Polymedics Innovations, GmbH. The 510(k) number is K170213.

When was SupraSDRM Biodegradable Matrix Wound Dressing approved by the FDA?

SupraSDRM Biodegradable Matrix Wound Dressing received FDA 510(k) clearance on 2017-06-28, under approval number K170213.

What company makes SupraSDRM Biodegradable Matrix Wound Dressing?

SupraSDRM Biodegradable Matrix Wound Dressing is manufactured by Polymedics Innovations, GmbH.

What is the FDA product code for SupraSDRM Biodegradable Matrix Wound Dressing?

The FDA product code for SupraSDRM Biodegradable Matrix Wound Dressing is QSZ.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07409571 Palatal Wound Healing After Free Gingival Graft Surgery RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING

Related PubMed Literature

PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Related Devices (Code: QSZ)

K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”Engineered Tissue Solutions, LLC K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)Polynovo Biomaterials Pty, Ltd. K170300Restrata Wound MatrixAcera Surgical, Inc. K173544Phoenix Wound MatrixNanofiber Solutions, Inc. K193583Restrata®Acera Surgical, Inc. K222189SiOxD Wound MatrixSioxmed, LLC

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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