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FDA 510(k)

COVAMAX RESORBABLE COLLAGEN MEMBRANE

K-Number: K103087 · 2011-08-26

ApplicantBiom'Up Sas
Decision Date2011-08-26
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COVAMAX RESORBABLE COLLAGEN MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Biom'Up Sas. It received FDA 510(k) clearance on 2011-08-26 under 510(k) number K103087. 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 COVAMAX RESORBABLE COLLAGEN MEMBRANE?

COVAMAX RESORBABLE COLLAGEN MEMBRANE is a medical device that received FDA 510(k) clearance on 2011-08-26. The listed applicant is Biom'Up Sas. The 510(k) number is K103087.

When did COVAMAX RESORBABLE COLLAGEN MEMBRANE receive FDA 510(k) clearance?

COVAMAX RESORBABLE COLLAGEN MEMBRANE received FDA 510(k) clearance on 2011-08-26, under 510(k) number K103087.

Who is the listed applicant for COVAMAX RESORBABLE COLLAGEN MEMBRANE?

The FDA 510(k) record lists Biom'Up Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COVAMAX RESORBABLE COLLAGEN MEMBRANE?

The FDA product code for COVAMAX RESORBABLE COLLAGEN MEMBRANE is NPL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biom'Up Sas 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.

K103081COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE

Related Devices (Code: NPL)

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.

K242817Jason membraneBotiss Biomaterials GmbHK250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AGK251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AGK250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AGK233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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