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TE ME NA Epidural Catheter

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

510(k) K991259

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK991259 Date21 Feb 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
BSO
Device Class
Class II
Regulation
21 CFR Part 868.5120
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The TE ME NA Epidural Catheter is a Class 2 device intended for administration of local anesthetics for regional anesthesia, including Epidural and Caudal anesthesia for up to 72 hours. It is a conduction anesthetic catheter with product code BSO.

The device is manufactured by Te ME NA S.A.R.L. and was cleared through the Traditional 510(k) pathway after a 680-day FDA review. It is authorized under FDA 510(k) clearance with K991259 and is intended for single use. The device is not specified as MRI safe and no specific sizes are mentioned in the data.

Other devices from Te ME NA S.A.R.L.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the TE ME NA Epidural Catheter used for?

    The TE ME NA Epidural Catheter is a Class 2 device intended for administration of local anesthetics for regional anesthesia, including Epidural and Caudal anesthesia for up to 72 hours.

  • Is the TE ME NA Epidural Catheter reusable or single-use?

    The TE ME NA Epidural Catheter is intended for single use only and should not be reused on multiple patients or procedures.

  • What is the regulatory status of the TE ME NA Epidural Catheter?

    The device was cleared through the Traditional 510(k) pathway after a 680-day FDA review and is authorized under FDA 510(k) clearance with K991259.

  • How long can the TE ME NA Epidural Catheter be used?

    The TE ME NA Epidural Catheter is designed for administration of local anesthetics for up to 72 hours during regional anesthesia procedures.