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Curity Calibrated Tuohy Type Epidural Needle

by Kendall Healthcare Products Co. Div.Of Tyco Health

510(k) K921288

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 NumberK921288 Date27 Jan 1993ClearedStatusActive

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  • Withdrawn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
BSP
Device Class
Class II
Regulation
21 CFR Part 868.5150
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Curity Calibrated Tuohy Type Epidural Needle is a conduction anesthetic needle used by clinicians for the induction of epidural anesthesia. It is designed to administer anesthetic to the peridural space.

This device is regulated under FDA 510(k) clearance. It is intended for use in an anesthesiology setting.

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Questions

AI-generated answers, 27 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 primary clinical use of the Curity Calibrated Tuohy Type Epidural Needle?

    This device is designed for use in an anesthesiology setting to facilitate the induction of epidural anesthesia by administering anesthetic agents into the peridural space.

  • Is this needle regulated for clinical use?

    Yes, the Curity Calibrated Tuohy Type Epidural Needle is regulated under FDA 510(k) clearance, which confirms it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

  • What medical specialty is this needle intended for?

    This device is specifically intended for use within the field of anesthesiology, as indicated by its classification under the anesthesiology advisory committee.