FDA.reportPublic FDA data

Single Use Preloaded Sphincterotome V(Distal Wireg

Primary DI
14953170371834
Brand
Single Use Preloaded Sphincterotome V(Distal Wireg
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
KD-VC631Q-07303A
Published
2016-09-21
Public version status
Update
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
14953170371834PackageGS11In Commercial Distribution
04953170371837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317037183414953170371834
04953170371837049531703718374953170371837

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
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
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16932503512227Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-08
16932503512210Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512234Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512241Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512258Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512265Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512272Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512289Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512296Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512302Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512319Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512326Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512333Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512340Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512357Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512364Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512371Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512388Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512395Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512401Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503512418Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513187Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513194Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
16932503513200Sterile SphincterotomeMicro-Tech (Nanjing) Co., Ltd.KNS2026-01-07
14953170466349Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
14953170466356Single Use 3-Lumen Needle Knife VOLYMPUS MEDICAL SYSTEMS CORP.KNS2025-12-18
00827002613508SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613512SureTome SWCOOK INCORPORATEDKNS2025-12-08
10827002613529SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002607842TeslatomeCOOK INCORPORATEDKNS2025-07-22