Device
This is a guillotine type automatic biopsy needle with a stylet with sample notch and a cm marked echogenic cutting cannula.
Manufacturer
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model: GVS1620 Catalog: GVS1620 DI: 08699158346492 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Description
This is a guillotine type automatic biopsy needle with a stylet with sample notch and a cm marked echogenic cutting cannula.
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: f67616a0-3af5-4bf1-93db-9215eea98abc
Distribution Status: In Commercial Distribution
DUNS Number: 503024386
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: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08699158346492
Type: Primary
Issuing Agency: GS1
GMDN
Code: 58990
Name: Side-notch biopsy gun handpiece/needle
Definition:
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.
FDA Product Codes
KNW
Instrument, Biopsy
Premarket Submissions
Submission Number: K223300
Supplement Number: 000
Environmental Conditions
Item #1 - Storage Handling Type: Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text: Keep away from sunlight
Item #2 - Storage Handling Type: Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text: Storage environment temperature between 5-30 degrees celsius