Biopsy needles
SharkCore
by Covidien LP
A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.
SharkCore 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 |
|---|---|---|---|
| C-22-05 | Needle Gauge 22 G | Not stated | Available |
| C-25-05 | Needle Gauge 25 G | Not stated | Available |
| DSC-22-01 | Needle Gauge 22 G | Not stated | Available |
| DSC-25-01 | Needle Gauge 25 G | Not stated | Available |
| DSL-19-01 | — | Not stated | Available |
| L-19-05 | — | Not stated | Available |
FDA clearances
- 510(k) K141894 October 2014
Procedures that use biopsy needles
Frequently asked questions
What is SharkCore used for?
A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.
Who makes SharkCore?
SharkCore is made by Covidien LP. It is listed under biopsy needles and systems in our device library.
What sizes does SharkCore come in?
Sizes listed for SharkCore: Needle Gauge: 22–25 G. Confirm availability with the manufacturer's instructions for use.
Is SharkCore MRI safe?
The FDA device database entry for SharkCore does not state its MRI safety status. Check the labeling before MRI.
Is SharkCore FDA cleared?
SharkCore is covered by FDA submission K141894.
How do I contact a Covidien LP sales representative?
Covidien LP has not listed representatives on LA Vascular yet. Visit the Covidien LP 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.