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510(k) K925437

Device
ACUFEX CANNULATED BONE TUNNEL PLUGS
Applicant
CUFEX MICROSURGICAL, INC.
510(k) number
K925437
Product code
HRX  
Decision
Substantially Equivalent (SESE)
Decision date
1992-12-24
Date received
1992-10-28
Regulation
888.1100
Classification name
Arthroscope
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LYNNE ARONSON
Address
130 Forbes Blvd. Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HRX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC2026-05-26
K253523Freedom DS™ Decompression SystemSpinal Simplicity2026-04-16
K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC2026-03-12
K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)2025-12-23
K250795PUREVUE™ FMSW.O.M. World of Medicine GmbH2025-12-05
K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC2025-11-21
K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.2025-11-03
K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.2025-10-15
K252594UltraGuideCTR® image guided soft tissue release systemSonex Health2025-09-29
K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations2025-08-27
K241990SpineSite Endoscope SystemHydrocision, Inc.2025-07-30
K243602Arthrex Spine EndoscopeArthrex, Inc.2025-05-16
K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC2024-12-11
K243020MIDASVuIntravu, Inc.2024-12-02
K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.2024-05-06

Legacy Summary#

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FDA Review#

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