FDA.reportPublic FDA data

Medtronic

Primary DI
06948318946785
Brand
Medtronic
Company
Anrei Medical(HZ) Co.,Ltd.
Model
EKM-425D
Device description
ProdiGI Single Use Electrosurgical Knife/ProdiGI Multi-Functional Electrosurgical Knife
Published
2022-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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
K212999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212999000Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd.2022-03-21KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948318946785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948318946785069483189467856948318946785

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical 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 may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529128653
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16948318903921RescueM00515100M005151002021-05-14
16948318903822RescueM00527450M005274502019-03-01
16948318903907RescueM00527650M005276502019-02-28
16948318903938RescueM00527750M005277502019-02-28
16948318903983RescueM00538350M005383502019-03-01
16948318968807RescueM00527550M005275502019-02-28
16926839812335NAM00591010M005910102025-10-27
16926839812366NAM00591200M005912002025-10-27
16926839812397NAM00591210M005912102025-10-27
16926839812427NAM00591220M005912202025-10-27
16926839812458NAM00591230M005912302025-10-27
16926839812489NAM00591240M005912402025-10-27
16926839812519NAM00591250M005912502025-10-27
16926839812304NAM00591000M005910002025-10-27
26926839812349NAM00591010M005910102025-10-27
26926839812370NAM00591200M005912002025-10-27
26926839812400NAM00591210M005912102025-10-27
26926839812431NAM00591220M005912202025-10-27
26926839812462NAM00591230M005912302025-10-27
26926839812493NAM00591240M005912402025-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809909424519SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424526SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424533SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424540SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424557SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909421709CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421716CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
04545499074423SB Knife Jr2SB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
04545499074430SB Knife Jr2 /Long typeSB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
00827002613515SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002613522SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002597501Tesla BicordCOOK INCORPORATEDKNS2025-07-11
00724995226732Padlock ClipUS EndoscopyKNS2024-10-31
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
04055207007822NARichard Wolf GmbHKNS2024-08-19
04055207008393NARichard Wolf GmbHKNS2024-08-19
04055207058985NARichard Wolf GmbHKNS2024-08-19
20653405051555APOLLO3Conmed CorporationKNS2024-07-22
20653405051562APOLLO3Conmed CorporationKNS2024-07-22
03665415002116Electrosurgical Unit MCBLAMIDEY NOURY MEDICALKNS2023-04-21
00851925007885Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.KNS2023-03-08
00884450329665Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502006Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502013Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502020Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450329658Brighton™Merit Medical Systems, Inc.KNS2021-06-15
00884450501993Brighton™Merit Medical Systems, Inc.KNS2021-06-15
00191506008086Axios™BOSTON SCIENTIFIC CORPORATIONKNS2021-05-27