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FDA 510(k)

Restrata®

K-Number: K193583 · 2020-09-25

ApplicantAcera Surgical, Inc.
Decision Date2020-09-25
Product CodeQSZ
DecisionSubstantially Equivalent

Device Summary

Restrata® is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K193583. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restrata®?

Restrata® is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K193583.

When did Restrata® receive FDA 510(k) clearance?

Restrata® received FDA 510(k) clearance on 2020-09-25, under 510(k) number K193583.

Who is the listed applicant for Restrata®?

The FDA 510(k) record lists Acera Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Restrata®?

The FDA product code for Restrata® is QSZ.

Related Clinical Trials

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.

NCT06578650A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous NeoplasmsRECRUITING

Other records listing Acera Surgical, Inc. 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.

K251224Restrata Soft Tissue Reinforcement (STR)K223725Restrata® MiniMatrixK172603Cerafix Dura SubstituteK170300Restrata Wound MatrixK161278Cerafix Dura SubstituteK153613Cerafix Dura Substitute

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Related Devices (Code: QSZ)

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.

K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.K241660SiOxD® Wound MatrixSioxmed, LLCK232847SiOxD Wound MatrixSioxmed, LLCK223725Restrata® MiniMatrixAcera Surgical, Inc.

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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