FDA.reportPublic FDA data

Hemoclip

Primary DI
06936603238073
Brand
Hemoclip
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-HC-16-230-O
Catalog number
ECA-23-230-16
Device description
Hemoclip, outer-tube diameter 2.5 mm, clip opening 16 mm, working length 2300 mm, plastic-coated
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230004000Disposable HemoclipYangzhou Fartley Medical Instrument Technology Co., Ltd.2023-07-31PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936603238070PackageGS110In Commercial Distribution
26936603238077PackageGS110In Commercial Distribution
06936603238073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323807016936603238070
2693660323807726936603238077
06936603238073069366032380736936603238073

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, long-term, non-bioabsorbableA non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.

Regulatory Flags#

DUNS number
544375774
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936603211625Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-RCPS-CR-24-02-10-2302026-10-22
06936603211649Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-NCPS-CS-24-02-10-2302026-10-22
06936603211724Disposable Polypectomy SnareFTL-PS-24-230-10-O-NSOV-DS-23-10-2302026-10-22
06936603211908Disposable Biopsy ForcepsFTL-BF-18-180-O-O-RTC11-ECO-S-18-180-SU2026-10-22
06936603211953Disposable Biopsy ForcepsFTL-BF-30-230-O-O-RTC11-ECO-30-230-SU2026-10-22
06936603211977Disposable Biopsy ForcepsFTL-BF-23-180-O-O-RTC11-SJ-23-180-SU2026-10-22
06936603212059Disposable Biopsy ForcepsFTL-BF-18-180-W-O-RTC12-ECO-S-18-180-SU2026-10-22
06936603212103Disposable Biopsy ForcepsFTL-BF-30-230-W-O-RTC12-ECO-30-230-SU2026-10-22
06936603212196ECO InjectFTL-IN-24-230-22-4IHN-23-22-4-2302026-10-22
06936603212202ECO InjectFTL-IN-24-230-22-5IHN-23-22-5-2302026-10-22
06936603212219ECO InjectFTL-IN-24-230-22-6IHN-23-22-6-2302026-10-22
06936603212240ECO InjectFTL-IN-24-230-23-4IHN-23-23-4-2302026-10-22
06936603212257ECO InjectFTL-IN-24-230-23-5IHN-23-23-5-2302026-10-22
06936603212271ECO InjectFTL-IN-24-230-25-5IHN-23-25-5-2302026-10-22
06936603212288ECO InjectFTL-IN-24-230-25-4IHN-23-25-4-2302026-10-22
06936603212295ECO InjectFTL-IN-24-230-25-6IHN-23-25-6-2302026-10-22
06936603212301Clean Connecting TubeFTL-EFC-IT-ETSIT-ETS-2102026-10-22
06936603212318Clean Connecting TubeFTL-EFC-IT-STD-FSIT-OUS-2102026-10-22
06936603212424Clean Connecting TubeFTL-EFC-O-H2-B1WBUC-HYB-OL42026-10-22
06936603212448Clean Connecting TubeFTL-EFC-O-S-B1WBUC-OL2-NC22026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603238059HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
06936603238066HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-10-22
16926839818887NAAnrei Medical(HZ) Co.,Ltd.PKL2026-10-19
16926839818917NAAnrei Medical(HZ) Co.,Ltd.PKL2026-10-19
03760441721113Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441721212Taurus Clip MiniTAURUS ENDOSCOPYPKL2026-09-22
03760441722110Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441722219Taurus ClipTAURUS ENDOSCOPYPKL2026-09-22
03760441723117Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
03760441723216Taurus Clip HemoTAURUS ENDOSCOPYPKL2026-09-22
06959664900086NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900178NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900185NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900192NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900291NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900307NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900314NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900543NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900550NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900574NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900598NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900635NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900666NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900697NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900840NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900864NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900871NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900888NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900895NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19
06959664900901NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-19