Vygon Spinal Anesthesia Needle W/Introducer 183
FDA 510(k) K851478 · Vygon Corp.
510(k) numberK851478
Submission
- Device name
- Vygon Spinal Anesthesia Needle W/Introducer 183
- Applicant
- Vygon Corp.
East Rutherford, NJ, US - Received
- April 15, 1985
- Decision date
- May 7, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BSP – Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Specialty
- Anesthesiology
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Questions and answers
When was Vygon Spinal Anesthesia Needle W/Introducer 183 cleared by the FDA?
Vygon Spinal Anesthesia Needle W/Introducer 183 (K851478) received a 510(k) decision of Substantially Equivalent on May 7, 1985, 22 days after the submission was received.
What is the product code of K851478?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.