Focus (TM) Echogenic Nerve Stimulating Needle
FDA 510(k) K101728 · Cook, Inc.
510(k) numberK101728
Submission
- Device name
- Focus (TM) Echogenic Nerve Stimulating Needle
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- June 21, 2010
- Decision date
- August 25, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 Focus (TM) Echogenic Nerve Stimulating Needle cleared by the FDA?
Focus (TM) Echogenic Nerve Stimulating Needle (K101728) received a 510(k) decision of Substantially Equivalent on August 25, 2010, 65 days after the submission was received.
What is the product code of K101728?
The FDA product code is BSP – Needle, Conduction, Anesthetic (W/Wo Introducer), a Class II (moderate risk) device regulated under 21 CFR 868.5150.