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Micro Z Blood Collecting Needles

by Hospital Products Co.

510(k) K823696

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 NumberK823696 Date26 Jan 1983ClearedStatusActive

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  • Withdrawn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
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Micro Z Blood Collecting Needles are blood collection needles used for obtaining blood specimens. They are designed for venipuncture procedures in clinical settings.

These needles are supplied sterile and intended for single-use only. They are regulated under FDA 510(k) clearance K823696, with product code FMI, and were cleared for marketing on January 26, 1983.

Other devices from Hospital Products Co.

Questions

AI-generated answers, 1 Oct 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 Micro Z Blood Collecting Needle used for?

    The Micro Z Blood Collecting Needle is used for obtaining blood specimens through venipuncture procedures in clinical settings, as it is specifically designed for this purpose to ensure safe and effective sample collection.

  • How is the Micro Z Blood Collecting Needle supplied and is it reusable?

    The Micro Z Blood Collecting Needle is supplied sterile and is intended for single-use only, meaning it should be discarded after one procedure to prevent cross-contamination and ensure patient safety.

  • What regulatory clearance does the Micro Z Blood Collecting Needle have?

    The Micro Z Blood Collecting Needle is regulated under FDA 510(k) clearance K823696, which was granted on January 26, 1983, based on a determination of substantial equivalence to a legally marketed predicate device.