TE ME NA POLYSTIM NERVE STIMILATOR— 510(k) K990323

Name: FDA 510(k) clearance K990323
Creator: U.S. Food and Drug Administration
Published: 2001-09-28

Substantially Equivalent

Te ME NA S.A.R.L.

FDA 510(k) clearance K990323 for TE ME NA POLYSTIM NERVE STIMILATOR, Substantially Equivalent on 2001-09-28. Applicant: Te ME NA S.A.R.L.. Device class: 2.

Clearance details

Applicant: Te ME NA S.A.R.L.
Product code: Code BXN
Device class: Class 2
Regulation: 21 CFR 868.2775
Advisory panel: Anesthesiology
Date received: 1999-02-02
Decision date: 2001-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

Download summary PDF View on FDA.gov ↗

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K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator2015-03-24
K140853 — STIMPOD ST2-3010 NERVE STIMULATOR2014-11-06

More clearances from Te ME NA S.A.R.L.

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K002405 — SPINAL EPIDURAL NEEDLES2001-06-01
K991259 — TE ME NA EPIDURAL CATHETER2001-02-21
K990100 — POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE2000-08-02
K990020 — TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC1999-06-24

Adverse events under product code BXN

product code BXN

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.