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FDA 510(k)

Soft Tissue Augmentation Resorbable Matrix

K-Number: K233203 · 2024-05-01

ApplicantCollagen Matrix, Inc.
Decision Date2024-05-01
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Soft Tissue Augmentation Resorbable Matrix is a medical device manufactured by Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2024-05-01 under approval number K233203. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soft Tissue Augmentation Resorbable Matrix?

Soft Tissue Augmentation Resorbable Matrix is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Collagen Matrix, Inc.. The 510(k) number is K233203.

When was Soft Tissue Augmentation Resorbable Matrix approved by the FDA?

Soft Tissue Augmentation Resorbable Matrix received FDA 510(k) clearance on 2024-05-01, under approval number K233203.

What company makes Soft Tissue Augmentation Resorbable Matrix?

Soft Tissue Augmentation Resorbable Matrix is manufactured by Collagen Matrix, Inc..

What is the FDA product code for Soft Tissue Augmentation Resorbable Matrix?

The FDA product code for Soft Tissue Augmentation Resorbable Matrix is NPL.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40001655 Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Collagen Matrix, Inc.

K152600Collagen Dental Wound Dressings K171008Anorganic Bone Mineral with Collagen in Delivery Applicator K170541Anorganic Bone Mineral in Delivery Applicator K170656Reinforced Flexible Collagen Nerve Cuff K162158Porcine Anorganic Bone Mineral in Delivery Applicator K182074Mineral Collagen Composite Bioactive Moldable

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Related Devices (Code: NPL)

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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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