RX EPIDURAL NEEDLE— 510(k) K053318
Substantially EquivalentEpimed International, Inc.
FDA 510(k) clearance K053318 for RX EPIDURAL NEEDLE, Substantially Equivalent on 2006-02-17. Applicant: Epimed International, Inc.. Device class: 2.
Clearance details
- Applicant
- Epimed International, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Johnstown, NY, US
Recent devices under product code BSP
view allMore clearances from Epimed International, Inc.
view all- K200624 — Percutaneous Introducer
- K190256 — Rulo Radiofrequency Lesion Probe
- K133316 — SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
- K051171 — STINGRAY EPIDURAL CATHETER CONNECTOR
- K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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 K053318
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053318.
Data sourced from openFDA. This site is unofficial and independent of the FDA.