FDA.reportPublic FDA data

Sterile Sphincterotome

Primary DI
06932503513012
Brand
Sterile Sphincterotome
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
DSP-30520-111111
Device description
Sterile Sphincterotome, lumen 3, TIP length 5, cutting wire 20, Outside diameter 2.5mm, Front end shape, no Rotation, no half Insulation, no preload guidewire, Single Cutting wire
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210934000Sphincterotome / short-wire compatible, Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.2021-12-01KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503513019PackageGS11In Commercial Distribution
26932503513016PackageGS125In Commercial Distribution
06932503513012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250351301916932503513019
2693250351301626932503513016
06932503513012069325035130126932503513012

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Atherectomy Cutter Length20Millimeter
Atherectomy Device Tip Length5Millimeter

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
06959664901069NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901076NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901595NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901663NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901687NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901700NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664901717NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664902646NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664903520NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910498NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910559NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910566NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910597NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664910764NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911921NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911976NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911983NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664911990NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912041NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912065NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912072NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912089NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912096NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912102NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664912119NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664919118NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934036NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934067NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934074NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17
06959664934098NAHangzhou AGS MedTech Co., Ltd.KNS2026-07-17