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FDA 510(k)

Pitch-Patchs

K-Number: K211563 · 2021-08-13

ApplicantXiros, Ltd.
Decision Date2021-08-13
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pitch-Patchs is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K211563. 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-Patchs?

Pitch-Patchs is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Xiros, Ltd.. The 510(k) number is K211563.

When did Pitch-Patchs receive FDA 510(k) clearance?

Pitch-Patchs received FDA 510(k) clearance on 2021-08-13, under 510(k) number K211563.

Who is the listed applicant for Pitch-Patchs?

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-Patchs?

The FDA product code for Pitch-Patchs 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.

NCT05264389Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) ReconstructionACTIVE_NOT_RECRUITINGNCT05906004Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator CuffRECRUITING

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)K230671Pitch PaSoft Tissue Reinforcement DeviceK222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220906SECURE-LOCKK191053Xtreme-Loop

View all 9 devices →

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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