FDA.reportPublic FDA data

Snare Tube

Primary DI
04953170035920
Brand
Snare Tube
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-10
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
FDISNARE, FLEXIBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955650000OLYMPUS SD SERIES SNARESOlympus America, Inc.1996-03-29FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170035920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170035920049531700359204953170035920

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn 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 is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002154Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002161Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002178Active working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002185Passive working element (SIDE load; round ; Fr26 ; STORZ compatible)LAMIDEY NOURY MEDICALFAS2023-04-21
08809327350926ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327350933ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327350940ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327350957ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327350964ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327350971ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327350988ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327350995ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351008ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351015ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351022ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08714729875604Signature Series PROSURG INCFAS2016-09-30
08714729747581SENSATION Short ThrowBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747598SENSATION Short ThrowBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747611SENSATION Short ThrowBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747628SENSATION Short ThrowBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747673CAPTIVATOR IIBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747680CAPTIVATORBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747703Rotatable SnareBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747710Rotatable SnareBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747833CAPTIVATORBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24
08714729747857CAPTIVATORBOSTON SCIENTIFIC CORPORATIONFDI2016-09-24