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Lab-Site Safety Needle

by Telos Medical Corp.

510(k) K905018

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 NumberK905018 Date16 Jan 1991ClearedStatusActive

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  • Withdrawn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
DQO
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Lab-Site Safety Needle is a medical device. It is classified under the product code DQO.

The device is supplied by Telos Medical Corp. and has been found to be substantially equivalent. It has FDA 510(k) clearance, with the clearance type being traditional, and the k number is K905018.

Other devices from Telos Medical Corp.

Questions

AI-generated answers, 21 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 Lab-Site Safety Needle used for?

    The Lab-Site Safety Needle is a medical device, but its specific use is not detailed in the provided information. It is classified under product code DQO.

  • Is the Lab-Site Safety Needle sterile?

    The provided information does not specify the sterility of the Lab-Site Safety Needle. Its packaging and sterility would depend on the manufacturer's specifications.

  • What is the regulatory status of the Lab-Site Safety Needle?

    The Lab-Site Safety Needle has FDA 510(k) clearance, with a k number of K905018, indicating it has been found substantially equivalent to other devices.