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FDA 510(k)

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

K-Number: K222978 · 2022-12-27

ApplicantXiros, Ltd.
Decision Date2022-12-27
Product CodeQUW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a medical device manufactured by Xiros, Ltd.. It received FDA 510(k) clearance on 2022-12-27 under approval number K222978. The device is classified under product code QUW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2022-12-27. It is manufactured by Xiros, Ltd.. The 510(k) number is K222978.

When was Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device approved by the FDA?

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device received FDA 510(k) clearance on 2022-12-27, under approval number K222978.

What company makes Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is manufactured by Xiros, Ltd..

What is the FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

The FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is QUW.

Related Clinical Trials

NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT05313555 The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin TERMINATED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT02030691 Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress COMPLETED NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING

Related PubMed Literature

PMID: 36883611 Safety and Efficacy of Renuvion Helium Plasma to Improve the Appearance of Loose Skin in the Neck and Submental Region. Aesthetic surgery journal (2023) PMID: 30005090 Straight-Line Vector Planning for Optimal Results With Silhouette InstaLift in Minimally Invasive Tissue Repositioning for Facial Rejuvenation. Journal of drugs in dermatology : JDD (2018) PMID: 25938303 Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database. JAMA internal medicine (2015)

Other Devices by Xiros, Ltd.

K171680Infinity-Lock 3, Infinity-Lock 5 K180243Infinity-Lock Button System K191053Xtreme-Loop K211563Pitch-Patchs K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device K220906SECURE-LOCK

View all 8 devices →

Related Devices (Code: QUW)

K242237Jewel Soft Tissue Reinforcement Device (102-6005)Xiros Limited K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro

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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