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FDA 510(k)

ULTRAPRO Mesh and ULTRAPRO ADVANCED

K-Number: K180910 · 2018-07-02

ApplicantETHICON, Inc.
Decision Date2018-07-02
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRAPRO Mesh and ULTRAPRO ADVANCED is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2018-07-02 under 510(k) number K180910. 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 ULTRAPRO Mesh and ULTRAPRO ADVANCED?

ULTRAPRO Mesh and ULTRAPRO ADVANCED is a medical device that received FDA 510(k) clearance on 2018-07-02. The listed applicant is ETHICON, Inc.. The 510(k) number is K180910.

When did ULTRAPRO Mesh and ULTRAPRO ADVANCED receive FDA 510(k) clearance?

ULTRAPRO Mesh and ULTRAPRO ADVANCED received FDA 510(k) clearance on 2018-07-02, under 510(k) number K180910.

Who is the listed applicant for ULTRAPRO Mesh and ULTRAPRO ADVANCED?

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 ULTRAPRO Mesh and ULTRAPRO ADVANCED?

The FDA product code for ULTRAPRO Mesh and ULTRAPRO ADVANCED is FTL.

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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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