510(k) K212328
K212328 is an FDA 510(k) premarket notification submitted by Disccath, LLC for the device "DiscCath Needle Set". The FDA issued a decision of Substantially Equivalent on September 26, 2021. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2021
- Date Received
- July 27, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type