FDA.reportPublic FDA data

DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME

Primary DI
14953170464567
Brand
DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
KD-411Q-0320
Catalog number
N6225631
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170464567PackageGS11In Commercial Distribution
04953170464560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317046456714953170464567
04953170464560049531704645604953170464560

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
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
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503516563Sphincterotome / short-wire compatibleMicro-Tech (Nanjing) Co., Ltd.KNS2026-06-27
00191506062620RIVOS™BOSTON SCIENTIFIC CORPORATIONKNS2026-06-25
08809909424502SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
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