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)

HYDROFIX SURGICAL SHEET

K-Number: K100313 · 2011-06-14

ApplicantMimedx Group, Inc.
Decision Date2011-06-14
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDROFIX SURGICAL SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Mimedx Group, Inc.. It received FDA 510(k) clearance on 2011-06-14 under 510(k) number K100313. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROFIX SURGICAL SHEET?

HYDROFIX SURGICAL SHEET is a medical device that received FDA 510(k) clearance on 2011-06-14. The listed applicant is Mimedx Group, Inc.. The 510(k) number is K100313.

When did HYDROFIX SURGICAL SHEET receive FDA 510(k) clearance?

HYDROFIX SURGICAL SHEET received FDA 510(k) clearance on 2011-06-14, under 510(k) number K100313.

Who is the listed applicant for HYDROFIX SURGICAL SHEET?

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

What is the FDA product code for HYDROFIX SURGICAL SHEET?

The FDA product code for HYDROFIX SURGICAL SHEET is FTL.

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 Mimedx Group, 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.

K111137HYDROFIX VASO SHIELDK101805HYDROFIX VASO SHIELDK101826HYDROFIX VASO SHIELD, MODEL HVS-001-0610K100905HYDROFIX SURGICAL SHEET

Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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.

↑