Device
The SUREcore Plus Biopsy Instrument, with a length of 25 cm, facilitates biopsy of soft tissue. It consists of a biopsy needle and an instrument ("gun"). The needle is advanced und...
Manufacturer
URO-1, INC.
URO-1, INC.
Model: SP-LA18-25
Catalog: SP-LA18-25
DI: 00860014338663
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Distribution End: 2029-12-31
Description
The SUREcore Plus Biopsy Instrument, with a length of 25 cm, facilitates biopsy of soft tissue. It consists of a biopsy needle and an instrument ("gun"). The needle is advanced under imaging to the target tissue and the instrument fires the needle into the tissue to obtain a core of tissue. The tissue core is than sent to pathology for analysis. It is a single-use device.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
56b57dbd-28fa-45a9-be9a-6dac80895333
Distribution Status:
In Commercial Distribution
DUNS Number:
082407801
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860014338663
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64326
Name: Biopsy gun handpiece, mechanical
Definition:
A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. 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 reusable device.
FDA Product Codes
KNW
Instrument, Biopsy