FDA.reportPublic FDA data

Hemoclip

Primary DI
16936603227715
Brand
Hemoclip
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-HC-09-230-O
Catalog number
MMC-230-09
Device description
rotating, Repositional Hemostasis Clip, 9mm
Published
2026-01-26
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
16936603227715PackageGS110In Commercial Distribution
26936603227712PackageGS110In Commercial Distribution
06936603227718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660322771516936603227715
2693660322771226936603227712
06936603227718069366032277186936603227718

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.

Sterilization Methods#

Method table
Method

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
06936603230978Cleaning SpongeFTL-BCS-S1-BZSEN-3ECS2025-06-23
06936603225707Basic Bedside KitFTL-IPK-AM2BBK-12024-02-26
06936603225691Disposable Cleaning BrushFTL-CB-V12-IVB-12024-01-30
06936603227718HemoclipFTL-HC-09-230-OMMC-230-092026-01-26
06936603228937Single Use Angulation Knob ExtenderFTL-DEK-AMAJ-22192025-12-03
06936603231739Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
16936603228934Single Use Angulation Knob ExtenderFTL-DEK-AMAJ-22192025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
06936603226902Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
16936603226909Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
06936603210567Disposable Endoscopy Valve SetFTL-VS-PI20-A1152822024-03-08
06936603216460Disposable Endoscopy Adapter SetsFTL-VS-P-A1152922024-03-08
06936603216477Disposable Endoscopy Adapter SetsFTL-VS-P-B11152932024-03-08
06936603216491Disposable Endoscopy Adapter SetsFTL-VS-P-K11152942024-03-08
06936603224403Disposable Endoscopy Valve SetFTL-VS-PI20-B1152832024-03-08
06936603224410Disposable Endoscopy Valve SetFTL-VS-PI20-C1152842024-03-08
06936603227947Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
16936603227944Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
06936603230862Bedside Cleaning SpongeFTL-BCS-S1-BZ-WSEN-BK-12025-06-23
06936603230879Basic Bedside KitFTL-IPK-GSEN-BK-22025-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913482NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915387NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915394NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915400NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915417NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915424NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915431NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915448NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915455NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915462NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915479NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915493NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915509NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915516NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915523NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915530NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915547NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915554NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915561NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915578NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915592NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915615NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915622NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915639NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915646NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915653NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915660NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915677NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915684NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16
06959664915691NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-16