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Jamshidi Marrow Acquisition Cradle

by Allegiance Healthcare Corp.

510(k) K003370

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 · Special NumberK003370 Date22 Nov 2000ClearedStatusActive

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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
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.

The Jamshidi Marrow Acquisition Cradle is a device used in conjunction with bone marrow biopsy and aspiration procedures. It is designed to support the acquisition of bone marrow samples during clinical use.

This device received FDA 510(k) clearance (K003370) on November 22, 2000, and is classified under product code KNW. It was determined to be substantially equivalent to a legally marketed device. The clearance was reviewed by the Gastroenterology-Urology advisory committee.

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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 Jamshidi Marrow Acquisition Cradle used for?

    The Jamshidi Marrow Acquisition Cradle is used in conjunction with bone marrow biopsy and aspiration procedures to support the acquisition of bone marrow samples during clinical use, as stated in the device description.

  • How is the Jamshidi Marrow Acquisition Cradle supplied or configured for use?

    The device is designed to be used alongside bone marrow biopsy and aspiration instruments to stabilize or guide the sampling process, though specific supply details like packaging or components are not provided in the data.

  • Is the Jamshidi Marrow Acquisition Cradle intended for single-use or reuse?

    The device data does not specify whether the Jamshidi Marrow Acquisition Cradle is intended for single-use or reuse, so this information cannot be determined from the provided details.

  • What regulatory pathway was used for the Jamshidi Marrow Acquisition Cradle?

    The Jamshidi Marrow Acquisition Cradle received FDA 510(k) clearance under K003370, indicating it was cleared via the 510(k) premarket notification pathway as substantially equivalent to a predicate device.

  • What are the key identifiers for the Jamshidi Marrow Acquisition Cradle?

    The device is identified by the name Jamshidi Marrow Acquisition Cradle, manufacturer Allegiance Healthcare Corp., FDA 510(k) number K003370, product code KNW, and clearance date of November 22, 2000.