ATRAUMATIC PENCIL POINT SPINAL NEEDLE— 510(k) K945965
Substantially EquivalentAvid N.I.T., Inc.
FDA 510(k) clearance K945965 for ATRAUMATIC PENCIL POINT SPINAL NEEDLE, Substantially Equivalent on 1995-08-02. Applicant: Avid N.I.T., Inc.. Device class: 2.
Clearance details
- Applicant
- Avid N.I.T., 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
- Tarpon Springs, FL, US
Recent devices under product code BSP
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view all- K014246 — AVID-NIT NERVE STIMULATION NEEDLES
- K013231 — AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
- K983218 — N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE
- K972595 — ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
- K972554 — REGANES RADIONUCLIDE SEED MAGAZINE
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.