Biopsy needles
Celero-12
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
Celero-12 models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| CELERO-12 | — | Not stated | Available |
FDA clearances
- 510(k) K034021 September 2004
Procedures that use biopsy needles
Frequently asked questions
What is Celero-12 used for?
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
Who makes Celero-12?
Celero-12 is made by Hologic, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Celero-12 come in?
The FDA device database does not list sizes for Celero-12. Check the instructions for use or ask a Hologic, Inc. representative.
Is Celero-12 MRI safe?
The FDA device database entry for Celero-12 does not state its MRI safety status. Check the labeling before MRI.
Is Celero-12 FDA cleared?
Celero-12 is covered by FDA submission K034021.
How do I contact a Hologic, Inc. sales representative?
Hologic, Inc. has not listed representatives on LA Vascular yet. Visit the Hologic, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.