Digital ClarusScope System; Digital NeuroPEN System— 510(k) K240535
Substantially EquivalentClarus Medical, LLC
FDA 510(k) clearance K240535 for Digital ClarusScope System; Digital NeuroPEN System, Substantially Equivalent on 2024-04-25. Applicant: Clarus Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Clarus Medical, LLC
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code HRX
view allMore clearances from Clarus Medical, LLC
view all- K223615 — Digital ClarusScope System, Digital NeuroPEN System
- K200925 — Clarus Peel-Away Introducer Sheath
- K082038 — CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
- K040919 — NUCLEOTOME PROBE SET, MODEL 21200
- K040424 — LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.