FDA.reportPublic FDA data

Olympus

Primary DI
04042761051866
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WA33036A
Catalog number
WA33036A
Device description
OP-telescope, 30°, 4 mm channel
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGAKit, Nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853486000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853486000OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPEOlympus Corp.1985-09-12FGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761051866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761051866040427610518664042761051866

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical nephroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the internal structures of the kidney and may be used in the removal of renal calculi. 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
Serial number
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
10810068811114MONARCH™ Mini-PCNL Suction SetAuris Health, Inc.FGA2026-05-05
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06925816667220ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816657511ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657528ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657535ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657542ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657559ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657566ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657573ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657580ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657597ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657603ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657627ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657634ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657641ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657658ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657672ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657689ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657696ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657702ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657719ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657726ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657733ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657740ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
04055207038666NARichard Wolf GmbHFGA2024-04-01