Skip to content

Pencil Point Spinal Needle and Tray

by B. Braun of America, Inc.

510(k) K932569

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932569 Date26 Jan 1994ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1666-2014 FDA Class II initiated 3 Apr 2014

    B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.

    • Terminated Z-1440-04 FDA Unclassified (pre-2012) initiated 6 Jul 2004

    drug ampuls in kits contain particulates

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from B. Braun of America, Inc.

See all devices from B. Braun of America, Inc. →