TE ME NA EPIDURAL CATHETER— 510(k) K991259

Name: FDA 510(k) clearance K991259
Creator: U.S. Food and Drug Administration
Published: 2001-02-21

Substantially Equivalent

Te ME NA S.A.R.L.

FDA 510(k) clearance K991259 for TE ME NA EPIDURAL CATHETER, Substantially Equivalent on 2001-02-21. Applicant: Te ME NA S.A.R.L.. Device class: 2.

Clearance details

Applicant: Te ME NA S.A.R.L.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 1999-04-13
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, FL, US

Download summary PDF View on FDA.gov ↗

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

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K990323 — TE ME NA POLYSTIM NERVE STIMILATOR2001-09-28
K002405 — SPINAL EPIDURAL NEEDLES2001-06-01
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 BSO

product code BSO

Malfunction: 688
Total: 688

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.