Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEOTRACT ANCHOR

K-Number: K061700 · 2006-10-26

ApplicantNeotract, Inc.
Decision Date2006-10-26
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEOTRACT ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2006-10-26 under 510(k) number K061700. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOTRACT ANCHOR?

NEOTRACT ANCHOR is a medical device that received FDA 510(k) clearance on 2006-10-26. The listed applicant is Neotract, Inc.. The 510(k) number is K061700.

When did NEOTRACT ANCHOR receive FDA 510(k) clearance?

NEOTRACT ANCHOR received FDA 510(k) clearance on 2006-10-26, under 510(k) number K061700.

Who is the listed applicant for NEOTRACT ANCHOR?

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

What is the FDA product code for NEOTRACT ANCHOR?

The FDA product code for NEOTRACT ANCHOR is GAW.

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 Neotract, Inc. 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.

K232558UroLift 2 ATC Advanced Tissue Control SystemK212396UroLift System Rigid Retrieval Kit Sterilization TrayK201837UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant CartridgeK200441UroLift Advanced Tissue Control (ATC) SystemK192781UroLift System Procedure Kit Sterilization TrayK193269UroLift System (UL400)

View all 16 devices →

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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.

↑