Imbibe Bone Marrow Aspiration Syringe
510(k) K023074
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023074 | Date11 Mar 2003 | 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- Withdrawn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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Imbibe Bone Marrow Aspiration Syringe is a piston syringe designed for the aspiration of bone marrow, autologous blood, plasma, or other blood components. It is classified as a bone marrow aspiration device, enabling minimally invasive collection from anatomical sites such as the iliac crest, vertebral body, or calcaneus without the complications associated with traditional harvesting methods.
This device is supplied sterile and intended for single-use. It is intended for use in surgical settings, where it is paired with the Imbibe Bone Marrow Aspiration Needle for collection purposes. The syringe may be pre-filled with a surgeon’s choice of bone void filler, such as allograft, autograft, or synthetic bone graft, prior to aspiration. Authorized for commercial distribution in the United States under an FDA 510(k) clearance (K023074)