Jamshidi Marrow Acquisition Cradle
by Allegiance Healthcare Corp.
510(k) K003370
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003370 | Date22 Nov 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Allegiance Healthcare Corp.
Questions
AI-generated answers, 1 Oct 2026
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.