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FDA 510(k)

Tigon Medical Tissue Anchors

K-Number: K182507 · 2019-01-21

ApplicantTigon Medical
Decision Date2019-01-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical Tissue Anchors is a medical device manufactured by Tigon Medical. It received FDA 510(k) clearance on 2019-01-21 under approval number K182507. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tigon Medical Tissue Anchors?

Tigon Medical Tissue Anchors is a medical device that received FDA 510(k) clearance on 2019-01-21. It is manufactured by Tigon Medical. The 510(k) number is K182507.

When was Tigon Medical Tissue Anchors approved by the FDA?

Tigon Medical Tissue Anchors received FDA 510(k) clearance on 2019-01-21, under approval number K182507.

What company makes Tigon Medical Tissue Anchors?

Tigon Medical Tissue Anchors is manufactured by Tigon Medical.

What is the FDA product code for Tigon Medical Tissue Anchors?

The FDA product code for Tigon Medical Tissue Anchors is MBI.

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 41269675 Pathology as a Core Discipline in the Biological Evaluation of Medical Devices. International journal of toxicology (2026) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

Other Devices by Tigon Medical

K211049Tigon Medical Button System K220464Tigon Medical Gryphon Anchor Line K242529Tigon Medical All-Suture Anchors (ASA) K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE) K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

View all 7 devices →

Related Devices (Code: MBI)

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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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