FDA.reportPublic FDA data

Snare

Primary DI
08809909421464
Brand
Snare
Company
TAEWOONGMEDICAL.CO.,LTD
Model
KSN22FHC-15
Catalog number
KSN22FHC-15
Device description
The Snare is designed to be used for without diathermic energy for the endoscopic resection of polyp tissue in the gastrointestinal tract.
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGXSnare, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809909421501PackageGS110In Commercial Distribution
08809909421464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809909421501088099094215018809909421501
08809909421464088099094214648809909421464

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-cutting endoscopic polypectomy snareA 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.

Contacts#

Phone, Email table
PhoneEmail
+82319960641contact@stent.net
323-692-0028minsoo@taewoongusa.com

Regulatory Flags#

DUNS number
689484322
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809909424502SphincterotomeOST0720OST07202026-05-29
08809909424519SphincterotomeOST0725OST07252026-05-29
08809909424526SphincterotomeOST0730OST07302026-05-29
08809909424533SphincterotomeOST0720SOST0720S2026-05-29
08809909424540SphincterotomeOST0725SOST0725S2026-05-29
08809909424557SphincterotomeOST0730SOST0730S2026-05-29
08809909421457SnareKSN22FHC-10KSN22FHC-102026-04-27
08809909421471SnareKSN22FHC-20KSN22FHC-202026-04-27
08809909421488SnareKSN22FYC-20KSN22FYC-202026-04-27
08809909421709CystotomeOCT1907OCT19072026-04-27
08809909421716CystotomeOCT1908OCT19082026-04-27
08809909421723Biopsy ForcepsJBFR160JBFR1602026-04-27
08809909421730Biopsy ForcepsJBFR160CJBFR160C2026-04-27
08809909421747Biopsy ForcepsBF160BF1602026-04-27
08809909421754Biopsy ForcepsBF160NBF160N2026-04-27
08809909421761Biopsy ForcepsBF160CBF160C2026-04-27
08809909421778Biopsy ForcepsBFR160BFR1602026-04-27
08809909421785Biopsy ForcepsBFR160NBFR160N2026-04-27
08809909421792Biopsy ForcepsBFR160CBFR160C2026-04-27
08809909421808Biopsy ForcepsGBF160GBF1602026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936534328911Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328928Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328935Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328942Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328959Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328966Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328973Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328980Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328997Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329000Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329017Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329024Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329031Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329048Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329055Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329062Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329079Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329086Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329093Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329109Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329116Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329123Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329130Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329147Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329154Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329161Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329178Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329185Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329192Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329208Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29