FDA Product Code BXN: Stimulator, Nerve, Battery-powered
Leading manufacturers include C.R. Bard, Inc., Xavant Technology (Pty), Ltd. and Intermedics, Inc..
63
Total
63
Cleared
124d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Stimulator, Nerve, Battery-powered Devices (Product Code BXN)
63 devices
Cleared
Oct 16, 2022
STIMPOD NMS450 Nerve Stimulator
Xavant Technology (Pty), Ltd.
Anesthesiology
389d
Cleared
Sep 19, 1979
BARD BIOMEDICAL NERVE LOCATOR
C.R. Bard, Inc.
Anesthesiology
60d
Cleared
Jun 13, 1979
NERVE STIMULATOR, DIGITAL PERIPHERAL
C.R. Bard, Inc.
Anesthesiology
7d
Cleared
Feb 06, 1979
STIMULATOR, BATTERY POWERED
Intermedics, Inc.
Anesthesiology
14d
About Product Code BXN - Regulatory Context
510(k) Submission Activity
63 total 510(k) submissions under product code BXN since 1976, with 63 receiving FDA clearance (average review time: 124 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.