LESIONPOINT RF CANNULA— 510(k) K053415
Substantially EquivalentCosman Medical, Inc.
FDA 510(k) clearance K053415 for LESIONPOINT RF CANNULA, Substantially Equivalent on 2006-04-25. Applicant: Cosman Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Cosman Medical, Inc.
- Product code
- Code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Recent devices under product code GXI
view allMore clearances from Cosman Medical, Inc.
view all- K101131 — FIDUCIAL MARKERS
- K082051 — COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
- K082012 — COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
- K060799 — COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
- K050084 — COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
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.