Pencan Spinal Needle
510(k) K112515
Pencan Spinal Needle is a Class II device made by B. Braun Medical, Inc., cleared under FDA 510(k) K112515 on 22 Dec 2011, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112515 | Date22 Dec 2011 | StatusActive |
Official records
- FDA 510(k) database K112515
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BSP
- FDA applicant
- B.Braun Medical, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5150
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
From the manufacturer
Pencan® Spinal Anesthesia Needles -. Pencan Pencil Point needles provide an atraumatic tip design. The special tip geometry results in low PDPH rates and superior tactile feedback, allowing for a distinct "dura click." The needle also is designed for minimal intrathecal insertion depth to protect against nerve injuries and paresthesia.
Similar devices
Other devices filed under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)).
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