FDA.reportPublic FDA data

MT

Primary DI
16932503530566
Brand
MT
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
ROCC-D-23-165-C
Device description
Open width11±1mm the max OD of insertion part 2.3mm working length 1650mm coated
Published
2023-06-28
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
K161463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161463000SureClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd.2017-01-06PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503530566PackageGS110In Commercial Distribution
26932503530563PackageGS110In Commercial Distribution
06932503530569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250353056616932503530566
2693250353056326932503530563
06932503530569069325035305696932503530569

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-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. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length165Centimeter
Outer Diameter2.3Millimeter

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
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
06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08
06932503575409Sphincterotome / short-wire compatibleRDSP-0220-2212026-05-08
06932503575416Sphincterotome / short-wire compatibleRDSP-0220-1312026-05-08
06932503575423Sphincterotome / short-wire compatibleRDSP-0220-2312026-05-08
06932503575430Sphincterotome / short-wire compatibleRDSP-0225-1112026-05-08
06932503575447Sphincterotome / short-wire compatibleRDSP-0225-2112026-05-08
06932503575454Sphincterotome / short-wire compatibleRDSP-0225-1212026-05-08

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