FDA.reportPublic FDA data

MT

Primary DI
16932503531235
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
HCCD-1-235-L-C
Device description
Clip Outer Diameter: φ17.0 mm, Working Length: 2350 mm, Endoscopy Dimension(φ): 11.5-14 mm, Outer Tube with Coating
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
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
16932503531235PackageGS11In Commercial Distribution
26932503531232PackageGS120In Commercial Distribution
06932503531238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250353123516932503531235
2693250353123226932503531232
06932503531238069325035312386932503531238

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
Length2350Millimeter
Outer Diameter17Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
530269083
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
false
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
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