Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACELL UBM SURGICAL MESH ML AND MLPLUS

K-Number: K041140 · 2004-07-07

ApplicantAcell, Inc.
Decision Date2004-07-07
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACELL UBM SURGICAL MESH ML AND MLPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2004-07-07 under 510(k) number K041140. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACELL UBM SURGICAL MESH ML AND MLPLUS?

ACELL UBM SURGICAL MESH ML AND MLPLUS is a medical device that received FDA 510(k) clearance on 2004-07-07. The listed applicant is Acell, Inc.. The 510(k) number is K041140.

When did ACELL UBM SURGICAL MESH ML AND MLPLUS receive FDA 510(k) clearance?

ACELL UBM SURGICAL MESH ML AND MLPLUS received FDA 510(k) clearance on 2004-07-07, under 510(k) number K041140.

Who is the listed applicant for ACELL UBM SURGICAL MESH ML AND MLPLUS?

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

What is the FDA product code for ACELL UBM SURGICAL MESH ML AND MLPLUS?

The FDA product code for ACELL UBM SURGICAL MESH ML AND MLPLUS is FTM.

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 Acell, 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.

K241724Cytal® Wound Matrix; Cytal® Burn MatrixK241706MicroMatrix® UBM ParticulateK230980MicroMatrix® FlexK191734MatriStem UBM Pericardial PatchK192725Cytal Wound Matrix 3-LayerK182259Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

View all 18 devices →

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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.

↑