510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Clarus Medical, LLC

Minneapolis, MN, US

CLARUS MEDICAL, LLC. appears in FDA device records in Minneapolis, MN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Clarus Medical, LLC between 2001 and 2026. The busiest year on record is 2002, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Clarus Medical, LLC, by decision year
YearClearances
20011
20022
20042
20091
20211
20231
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252790Digital ClarusScope System and Digital NeuroPEN SystemHRXSubstantially Equivalent
K240535Digital ClarusScope System; Digital NeuroPEN SystemHRXSubstantially Equivalent
K223615Digital ClarusScope System, Digital NeuroPEN SystemGWGSubstantially Equivalent
K200925Clarus Peel-Away Introducer SheathGWGSubstantially Equivalent
K082038CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-VBTRSubstantially Equivalent
K040919NUCLEOTOME PROBE SET, MODEL 21200HRXSubstantially Equivalent
K040424LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120GEXSubstantially Equivalent
K022610CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160GEXSubstantially Equivalent
K021848CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160GEXSubstantially Equivalent
K011454SPINE SCOPE, MODEL 2180HRXSubstantially Equivalent

Registered establishments

FDA registered establishments for Clarus Medical, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21839111000116142CLARUS MEDICAL, LLC.13355 10th Ave N Ste 110, Minneapolis, MN 55441 US2026and 2 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2405-2021Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002The sterile barrier seal may be compromised.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain