FDA.reportPublic FDA data

SD HANDLE

Primary DI
04953170035562
Brand
SD HANDLE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MH-264
Device description
"""MH-264 SD / FD HANDLE FOR REUSABLE SN AR"""
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
04953170035562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170035562049531700355624953170035562

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during argon-enhanced electrosurgery. 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
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
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
08809327351664ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351671ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351688ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351695ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351701ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351718ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351725ClearGrasp SnareFINEMEDIX CO.,LTD.FDI2019-04-12
08809327351732ClearGrasp 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