Device
The Snare is designed to be used for without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract.
Manufacturer
TAEWOONGMEDICAL.CO.,LTD
TAEWOONGMEDICAL.CO.,LTD
Model: KSN22FHC-20
Catalog: KSN22FHC-20
DI: 08809909421471
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
The Snare is designed to be used for without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6338ca3a-6db0-4b8f-b4ce-57d3a6b5f08d
Distribution Status:
In Commercial Distribution
DUNS Number:
689484322
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
08809909421518
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08809909421471
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08809909421471
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 62615
Name: Mechanical-cutting endoscopic polypectomy snare
Definition:
A sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.
FDA Product Codes
FGX
Snare, Non-Electrical