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Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle

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

510(k) K990100

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

19 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 NumberK990100 Date2 Aug 2000ClearedStatusActive

Recalls

19 recalls · FDA

  • 19 recalls, same reason

    • Terminated Z-2371-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2370-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2377-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2368-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2367-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2366-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2365-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2361-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2376-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2378-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2379-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2373-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2364-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2374-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2375-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2362-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2369-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2372-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010
    • Terminated Z-2363-2010 FDA Unclassified (pre-2012) initiated 1 Feb 2010

    Defects include, but not limited to: Not sterile, not properly labeled, drugs and swabs may be ineffective, and catheter tips may break in patients.

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  • Withdrawn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
GXZ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 882.1350
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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