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FDA 510(k)

T-Line Hernia Mesh

K-Number: K221556 · 2022-11-28

ApplicantDeep Blue Medical Advances, Inc.
Decision Date2022-11-28
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

T-Line Hernia Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Deep Blue Medical Advances, Inc.. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K221556. 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 T-Line Hernia Mesh?

T-Line Hernia Mesh is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Deep Blue Medical Advances, Inc.. The 510(k) number is K221556.

When did T-Line Hernia Mesh receive FDA 510(k) clearance?

T-Line Hernia Mesh received FDA 510(k) clearance on 2022-11-28, under 510(k) number K221556.

Who is the listed applicant for T-Line Hernia Mesh?

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

What is the FDA product code for T-Line Hernia Mesh?

The FDA product code for T-Line Hernia Mesh 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.

NCT05424484Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia OccurrenceACTIVE_NOT_RECRUITING

Other records listing Deep Blue Medical Advances, 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.

K232924T-Line® Hernia MeshK230227T-Line Hernia MeshK193144T-Line Hernia Mesh

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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