FDA.reportPublic FDA data

Disposable Hemostatic Clips

Primary DI
16974529068890
Brand
Disposable Hemostatic Clips
Company
Ningbo Xinwell Medical Technology Co., Ltd.
Model
XY-ZZJ-0B-2.5-2700-90-13
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
16974529068890PackageGS110In Commercial Distribution
26974529068897PackageGS15In Commercial Distribution
06974529068893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697452906889016974529068890
2697452906889726974529068897
06974529068893069745290688936974529068893

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
06971944910141Closed Suction CathetersH1064002025-03-04
06971944910158Closed Suction CathetersH1084002025-03-04
06971944910165Closed Suction CathetersH1104002025-03-04
06971944910172Closed Suction CathetersH1124002025-03-04
06971944910189Closed Suction CathetersH1144002025-03-04
06971944910196Closed Suction CathetersH1164002025-03-04
06971944910202Closed Suction CathetersH1184002025-03-04
06971944910219Closed Suction CathetersH1106002025-03-04
06971944910226Closed Suction CathetersH1126002025-03-04
06971944910233Closed Suction CathetersH1146002025-03-04
06971944910240Closed Suction CathetersH1166002025-03-04
06971944910257Closed Suction CathetersH1186002025-03-04
06971944910264Closed Suction CathetersH2064002025-03-04
06971944910271Closed Suction CathetersH2084002025-03-04
06971944910288Closed Suction CathetersH2104002025-03-04
06971944910295Closed Suction CathetersH2124002025-03-04
06971944910301Closed Suction CathetersH2144002025-03-04
06971944910318Closed Suction CathetersH2164002025-03-04
06971944910325Closed Suction CathetersH2184002025-03-04
06971944910332Closed Suction CathetersH2106002025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664915868NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915875NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915882NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915899NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915912NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915936NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915943NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915950NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915967NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915974NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915981NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916094NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916100NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916117NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916124NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916131NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916292NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916308NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916315NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916322NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916339NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916346NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916353NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916360NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916490NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916506NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916513NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916520NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916537NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916698NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23