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FDA 510(k)

NANOTACK SUTURE ANCHOR 1.4MM

K-Number: K110473 · 2011-05-25

ApplicantPivot Medical
Decision Date2011-05-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NANOTACK SUTURE ANCHOR 1.4MM is the device name listed in this FDA 510(k) record. The listed applicant is Pivot Medical. It received FDA 510(k) clearance on 2011-05-25 under 510(k) number K110473. 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 NANOTACK SUTURE ANCHOR 1.4MM?

NANOTACK SUTURE ANCHOR 1.4MM is a medical device that received FDA 510(k) clearance on 2011-05-25. The listed applicant is Pivot Medical. The 510(k) number is K110473.

When did NANOTACK SUTURE ANCHOR 1.4MM receive FDA 510(k) clearance?

NANOTACK SUTURE ANCHOR 1.4MM received FDA 510(k) clearance on 2011-05-25, under 510(k) number K110473.

Who is the listed applicant for NANOTACK SUTURE ANCHOR 1.4MM?

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

What is the FDA product code for NANOTACK SUTURE ANCHOR 1.4MM?

The FDA product code for NANOTACK SUTURE ANCHOR 1.4MM is MBI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pivot Medical 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.

K123651CINCHLOCK KNOTLESS SUTURE ANCHOR

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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