FDA.reportPublic FDA data

Assurance

Primary DI
10724995219168
Brand
Assurance
Company
US Endoscopy
Model
00711887
Catalog number
00711887
Device description
The Assurance Control Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within the digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation.
Published
2022-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
K172727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172727000HemoclipHangzhou AGS MedTech Co., Ltd.2018-04-16PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995219168PackageGS110In Commercial Distribution
00724995219161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499521916810724995219168
00724995219161007249952191617249952191610724995219161

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.6Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
627879687
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
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
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