510(k) K190026
K190026 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)". The FDA issued a decision of Substantially Equivalent on August 21, 2019. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Teleflex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2019
- Date Received
- January 7, 2019
- 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