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Te Me Na Polystim Nerve Stimilator

by Te ME NA S.A.R.L.

510(k) K990323

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990323 Date28 Sep 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2360-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010

    Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.

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  • Withdrawn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
BXN
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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