HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED— 510(k) K080603
Substantially EquivalentTe ME NA Sas
FDA 510(k) clearance K080603 for HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED, Substantially Equivalent on 2008-08-05. Applicant: Te ME NA Sas. Device class: 2.
Clearance details
- Applicant
- Te ME NA Sas
- 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
- Appollo Beach, FL, US
Recent devices under product code BSP
view allMore clearances from Te ME NA Sas
view allAdverse 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 K080603
K-number listed on FDA's recall record- Z-1608-2014 — Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
- Z-1609-2014 — Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080603.
Data sourced from openFDA. This site is unofficial and independent of the FDA.