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FDA 510(k)

Pitch PaSoft Tissue Reinforcement Device

K-Number: K230671 · 2023-05-31

ApplicantXiros, Ltd.
Decision Date2023-05-31
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pitch PaSoft Tissue Reinforcement Device is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K230671. 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 Pitch PaSoft Tissue Reinforcement Device?

Pitch PaSoft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Xiros, Ltd.. The 510(k) number is K230671.

When did Pitch PaSoft Tissue Reinforcement Device receive FDA 510(k) clearance?

Pitch PaSoft Tissue Reinforcement Device received FDA 510(k) clearance on 2023-05-31, under 510(k) number K230671.

Who is the listed applicant for Pitch PaSoft Tissue Reinforcement Device?

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

What is the FDA product code for Pitch PaSoft Tissue Reinforcement Device?

The FDA product code for Pitch PaSoft Tissue Reinforcement Device 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.

NCT05906004Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator CuffRECRUITINGNCT05264389Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) ReconstructionACTIVE_NOT_RECRUITING

Other records listing Xiros, Ltd. 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.

K242237Jewel Soft Tissue Reinforcement Device (102-6005)K222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220906SECURE-LOCKK211563Pitch-PatchsK191053Xtreme-Loop

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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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