FDA.reportPublic FDA data

Olympus

Primary DI
04042761000697
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
02160
Catalog number
02160
Device description
Knife, acc. to Otis, spare for O0216
Published
2016-09-22
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
EZOUrethrotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZOUrethrotomeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950719000OES UROLOGYOlympus America, Inc.1996-12-11EZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761000697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761000697040427610006974042761000697

GMDN Terms#

Term, Definition table
TermDefinition
UrethrotomeA surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. 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
316957240
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761082297OlympusWA03300AWA03300A2016-09-22
04042761082303OlympusWA03310AWA03310A2016-09-22
14042761083369OlympusWT645010WT6450102023-06-20
04042761083324OlympusWT806450WT8064502023-01-27
04042761081757OlympusWA97013AWA97013A2023-06-20
04042761083102OlympusWT2187002023-06-20
04042761083119OlympusWT2187052023-06-20
04042761083126OlympusWT2187112023-06-20
04042761083133OlympusWT2187202023-06-20
04042761083140OlympusWT6304002023-06-20
04042761083164OlympusWT6400212023-06-20
04042761083171OlympusWT645001WT6450012023-06-20
04042761083188OlympusWT645006WT6450062023-06-20
04042761083218OlympusWT645013WT6450132023-06-20
04042761083225OlympusWT645016WT6450162023-06-20
04042761083232OlympusWT645017WT6450172023-06-20
04042761083256OlympusWT645020WT6450202023-06-20
04042761083263OlympusWT645025WT6450252023-06-20
04042761083270OlympusWT645030WT6450302023-06-20
04042761083287OlympusWT645031WT6450312023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551232378n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
04048551232781n.a.Karl Storz GmbH & Co. KGEZO2025-08-11
00810143891263Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-09-27
00810143890914Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2024-04-15
00850033250756Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250886Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250893Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250909Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250916Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00850033250923Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.EZO2022-06-08
00190776156718MillenniumAvalign Technologies, Inc.EZO2020-11-25
00848657076494AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00848657085083AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EZO2019-06-14
00842331119019Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119026Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119033Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119040Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119057Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
00842331119064Novo SurgicalNOVO SURGICAL, INC.EZO2019-05-06
04046826063023MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04046826063030MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04046826063047MediconMedicon eG. Chirurgiemechaniker-GenossenschaftEZO2018-11-13
04048551233986n.a.Karl Storz GmbH & Co. KGEZO2018-09-04
04059082029757Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20
04059082029764ObturatorSOPRO-COMEG GmbHEZO2018-03-20
04059082029771Urethrotomy tubeSOPRO-COMEG GmbHEZO2018-03-20
04059082029788Urethrotomy bridgeSOPRO-COMEG GmbHEZO2018-03-20
04059082029795Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029801Urethrotomy knifeSOPRO-COMEG GmbHEZO2018-03-20
04059082029818Urethrotomy sheathSOPRO-COMEG GmbHEZO2018-03-20