FDA.reportPublic FDA data

CLARUS MEDICAL, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21839111000116142CLARUS MEDICAL, LLC.1N2026-01-0113355 10th Ave N Ste 110 Minneapolis MN US 55441

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
117591966565945K974579PERCSCOPE MODEL 2600HRX1998-02-18
117591242540243K971455CLARUS MODEL 5197 SIGHTLITEFTI1997-05-20
117591540746975K962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)EOB1996-09-11
117591257097020K945633NEURO CHANNEL ENDOSCOPE MODEL 2232GWG1995-09-19
117591102050304K942249CLARUS NEUROPEN MODEL 2120GWG1994-11-04
117592064736652K922881CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISCGEX1992-11-16
117592033813066K912447SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200FET1991-09-27
117591744034287K844131NUCLEOTOMEHSZ1984-11-29
117591564205948K240535Digital ClarusScope System; Digital NeuroPEN SystemHRX2024-04-25
117591671948915K223615Digital ClarusScope System, Digital NeuroPEN SystemGWG2023-11-21
117591351609777K200925Clarus Peel-Away Introducer SheathGWG2021-03-18
117591688941056K082038CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-VBTR2009-04-28
117591777604891K040919NUCLEOTOME PROBE SET, MODEL 21200HRX2004-06-01
117591737995221K040424LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120GEX2004-05-11
117591101780005
117591297180345
117591311199382

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWG42023-11-21
HRX32024-04-25
GEX22004-05-11
BTR12009-04-28
FTI11997-05-20
EOB11996-09-11
FET11991-09-27
HSZ11984-11-29

PMN#