FDA.reportPublic FDA data

S.T.A.R(TM) Disposable Hemostatic Closure Clip Device

Primary DI
06932503531122
Brand
S.T.A.R(TM) Disposable Hemostatic Closure Clip Device
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
HCCD-0-270-M-C
Device description
Clip Outer Diameter: φ14.5 mm, Working Length: 2700 mm, Endoscopy Dimension(φ): 9.5-12 mm, Outer Tube with Coating
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K220157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220157000Disposable Hemostatic Closure Clip DeviceMicro-Tech (Nanjing) Co., Ltd.2022-06-13PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503531129PackageGS11In Commercial Distribution
26932503531126PackageGS120In Commercial Distribution
06932503531122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250353112916932503531129
2693250353112626932503531126
06932503531122069325035311226932503531122

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
Length2700Millimeter
Outer Diameter14.5Millimeter

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
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
06932503516563Sphincterotome / short-wire compatibleRDSP-0230-231-22026-06-27
06932503540353Disposable Biopsy Forceps1005751005752020-03-23
06932503540360Disposable Biopsy Forceps1005761005762020-03-23
06932503540377Disposable Biopsy Forceps1005771005772020-03-23
06932503540384Disposable Biopsy Forceps1005781005782020-03-23
06932503510219Pulmonary Hydro-Slide GuidewireGW-35/182026-05-29
06932503510226Pulmonary Hydro-Slide GuidewireGW-35/262026-05-29
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08
06932503516204Sphincterotome / short-wire compatibleRDSP-0530-231-12026-05-08
06932503575379Sphincterotome / short-wire compatibleRDSP-0220-1112026-05-08
06932503575386Sphincterotome / short-wire compatibleRDSP-0220-2112026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664915998NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916001NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916018NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916025NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916032NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916049NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916056NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916063NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916070NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916087NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916148NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916155NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916162NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916179NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916186NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916193NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916209NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916216NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916223NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916230NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916247NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916254NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916261NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916278NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916285NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916377NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916384NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916391NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916407NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31
06959664916414NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-31