Clarus Medical, Llc
FDA Regulatory Profile
Clarus Medical, Llc appears in FDA public data with 1 recall, 10 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2405-2021, Class II) was initiated on July 27, 2021. Its most recent 510(k) clearance was granted on May 26, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2405-2021 | Class II | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 110 | July 27, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | May 26, 2026 |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | April 25, 2024 |
| K223615 | Digital ClarusScope System, Digital NeuroPEN System | November 21, 2023 |
| K200925 | Clarus Peel-Away Introducer Sheath | March 18, 2021 |
| K082038 | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V | April 28, 2009 |
| K040919 | NUCLEOTOME PROBE SET, MODEL 21200 | June 1, 2004 |
| K040424 | LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120 | May 11, 2004 |
| K022610 | CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 | November 5, 2002 |
| K021848 | CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 | September 3, 2002 |
| K011454 | SPINE SCOPE, MODEL 2180 | December 13, 2001 |