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FDA 510(k)

PROLENE Soft Polypropylene Mesh

K-Number: K163152 · 2017-03-11

ApplicantETHICON, Inc.
Decision Date2017-03-11
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROLENE Soft Polypropylene Mesh is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2017-03-11 under 510(k) number K163152. 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 PROLENE Soft Polypropylene Mesh?

PROLENE Soft Polypropylene Mesh is a medical device that received FDA 510(k) clearance on 2017-03-11. The listed applicant is ETHICON, Inc.. The 510(k) number is K163152.

When did PROLENE Soft Polypropylene Mesh receive FDA 510(k) clearance?

PROLENE Soft Polypropylene Mesh received FDA 510(k) clearance on 2017-03-11, under 510(k) number K163152.

Who is the listed applicant for PROLENE Soft Polypropylene Mesh?

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

What is the FDA product code for PROLENE Soft Polypropylene Mesh?

The FDA product code for PROLENE Soft Polypropylene Mesh is FTL.

Related Clinical Trials

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NCT04829058GYNEMESH PS Mesh Post Marketing Clinical Follow-Up StudyRECRUITINGNCT04829175Ethicon Pelvic Mesh Post Market Clinical Follow-up RegistryRECRUITINGNCT04829357Post Market Clinical Follow-up Study on TVT ABBREVO® Continence SystemRECRUITINGNCT04829994Post-Market Clinical Follow-Up onTVT EXACT® Continence SystemACTIVE_NOT_RECRUITINGNCT06664788A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open SurgeryRECRUITINGNCT07649434Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal HerniaNOT_YET_RECRUITING

Other records listing ETHICON, 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.

PMA N12159Agent, absorbable hemostatic, non-collagen basedPMA P880047Barrier, absorbable, adhesionPMA P240035Agent, absorbable hemostatic, collagen with polymeric additivesK253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

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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.

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