FDA.reportPublic FDA data

Disposable Hemostatic Clips

Primary DI
16974529067817
Brand
Disposable Hemostatic Clips
Company
Ningbo Xinwell Medical Technology Co., Ltd.
Model
XY-ZZJ-0A-2.5-1950-135-13
Device description
Disposable Hemostatic Clips
Published
2024-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K232969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232969000Disposable Hemostatic ClipsNingbo Xinwell Medical Technology Co., Ltd.2024-06-07PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16974529067817PackageGS110In Commercial Distribution
26974529067814PackageGS15In Commercial Distribution
06974529067810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697452906781716974529067817
2697452906781426974529067814
06974529067810069745290678106974529067810

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544587864
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26971944910145Closed Suction CathetersH1064002025-03-04
26971944910152Closed Suction CathetersH1084002025-03-04
26971944910169Closed Suction CathetersH1104002025-03-04
26971944910176Closed Suction CathetersH1124002025-03-04
26971944910183Closed Suction CathetersH1144002025-03-04
26971944910190Closed Suction CathetersH1164002025-03-04
26971944910206Closed Suction CathetersH1184002025-03-04
26971944910213Closed Suction CathetersH1106002025-03-04
26971944910220Closed Suction CathetersH1126002025-03-04
26971944910237Closed Suction CathetersH1146002025-03-04
26971944910244Closed Suction CathetersH1166002025-03-04
26971944910251Closed Suction CathetersH1186002025-03-04
26971944910268Closed Suction CathetersH2064002025-03-04
26971944910275Closed Suction CathetersH2084002025-03-04
26971944910282Closed Suction CathetersH2104002025-03-04
26971944910299Closed Suction CathetersH2124002025-03-04
26971944910305Closed Suction CathetersH2144002025-03-04
26971944910312Closed Suction CathetersH2164002025-03-04
26971944910329Closed Suction CathetersH2184002025-03-04
26971944910336Closed Suction CathetersH2106002025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16959664914516NAHangzhou AGS MedTech Co., Ltd.PKL2026-03-24
16936603227715HemoclipYangzhou Fartley Medical Instrument Technology Co., LtdPKL2026-01-26
06975543351923AltonAlton (Shanghai) Medical Instruments Co., Ltd.PKL2026-01-26
06975543351947AltonAlton (Shanghai) Medical Instruments Co., Ltd.PKL2026-01-26
06975543352005AltonAlton (Shanghai) Medical Instruments Co., Ltd.PKL2026-01-26
06975543352029AltonAlton (Shanghai) Medical Instruments Co., Ltd.PKL2026-01-26
16959664903145NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664903152NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664903930NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664903947NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664903961NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914219NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914226NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914233NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914240NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914257NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914264NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914295NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914301NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914318NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914332NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914349NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914356NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914370NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914387NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914394NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914417NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914424NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914431NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25
16959664914455NAHangzhou AGS MedTech Co., Ltd.PKL2026-01-25