FDA.reportPublic FDA data

Assurance

Primary DI
00724995220693
Brand
Assurance
Company
US Endoscopy
Model
00711927
Catalog number
00711927
Device description
The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpose of mechanical pressure treatment of bleeding of small arteries and pulsation.
Published
2023-03-22
Public version status
New
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
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
10724995220690PackageGS110In Commercial Distribution
50724995220698PackageGS110In Commercial Distribution
00724995220693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499522069010724995220690
5072499522069850724995220698
00724995220693007249952206937249952206930724995220693

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.

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
10197344203437MEDLINEMEDLINE INDUSTRIES, INC.PKL2026-04-23
10197344203444MEDLINEMEDLINE INDUSTRIES, INC.PKL2026-04-23
00860014822704EndoFix Tissue Fixation DeviceEndofix Medical Technologies, Inc.PKL2026-02-02
00860014822711Secure Suture Locking DeviceEndofix Medical Technologies, Inc.PKL2026-02-02
46932503530819Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530833Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530840Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530864Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530871Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530895Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530918Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530932Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530956Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530970Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530994Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535012Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535029Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535036Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535043Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503535050Lockado(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-06
46932503530666RiteClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-02
46932503530727RiteClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-12-02
46932503530390SureClip(®MINI) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530413SureClip(®MINI) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530420SureClip(®) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530444SureClip(®) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530451SureClip(®PLUS) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530468SureClip(®PLUS) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530512SureClip(®MAX) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30
46932503530529SureClip(®MAX) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.PKL2025-11-30