FDA.reportPublic FDA data

Padlock Clip

Primary DI
00724995184247
Brand
Padlock Clip
Company
US Endoscopy
Model
C910001
Catalog number
C910001
Device description
The Padlock Clip defect closure system is used in flexible endoscopy for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
Published
2020-04-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K120814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120814000PADLOCK CLIP-12Aponos Medical Corp.2012-09-06PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816765013793PreviousGS10
00724995184247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816765013793008167650137938167650137930816765013793
00724995184247007249951842477249951842470724995184247

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, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length162Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664917299NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917305NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917312NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917329NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664917336NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919712NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919729NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919736NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919743NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664919750NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920169NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920176NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920183NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920190NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920206NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920305NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920312NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920329NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920336NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920343NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920350NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920510NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920527NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920534NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920541NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920558NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920763NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920770NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920787NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07
06959664920794NAHangzhou AGS MedTech Co., Ltd.PKL2026-08-07