RF INTRODUCTION CANNULA— 510(k) K041021
Substantially EquivalentEpimed International, Inc.
FDA 510(k) clearance K041021 for RF INTRODUCTION CANNULA, Substantially Equivalent on 2004-09-16. Applicant: Epimed International, Inc.. Device class: 2.
Clearance details
- Applicant
- Epimed International, 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
- Johnstown, NY, US
Recent devices under product code GXI
view allMore clearances from Epimed International, Inc.
view allAdverse 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 →
Recalls naming K041021
K-number listed on FDA's recall record- Z-1849-2020 — R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
- Z-1850-2020 — R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041021.
Data sourced from openFDA. This site is unofficial and independent of the FDA.