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Clarus Medical, Llc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
9
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2405-2021Class IILase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 110July 27, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K240535Digital ClarusScope System; Digital NeuroPEN SystemApril 25, 2024
K223615Digital ClarusScope System, Digital NeuroPEN SystemNovember 21, 2023
K200925Clarus Peel-Away Introducer SheathMarch 18, 2021
K082038CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-VApril 28, 2009
K040919NUCLEOTOME PROBE SET, MODEL 21200June 1, 2004
K040424LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120May 11, 2004
K022610CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160November 5, 2002
K021848CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160September 3, 2002
K011454SPINE SCOPE, MODEL 2180December 13, 2001