FDA.reportPublic FDA data

OTV-S700 UPGRADE PACK 3D

Primary DI
04953170445453
Brand
OTV-S700 UPGRADE PACK 3D
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2511
Catalog number
N6189440
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242067000VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EAOlympus Corporations of the Americas2025-04-02FET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170445453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170445453049531704454534953170445453

GMDN Terms#

Term, Definition table
TermDefinition
Software upgrade/unlocking keyA software, hardware, or software/hardware combination device intended to be used to update/upgrade/unlock software embedded on a medical device through the use of an integral or separate media device (e.g., USB flash drive, CD). If supplied on a dedicated USB drive, it may be otherwise known as a ‘dongle’. This is a reusable 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
Serial number
true
Manufacturing date on label
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840432200308CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200315CystoView™Verathon Medical (Canada) ULCFET2026-05-15
00840432200322CystoView™Verathon Medical (Canada) ULCFET2026-05-15
04048551418123n.a.Karl Storz GmbH & Co. KGFET2025-08-11
04250480104262N/ASCHÖLLY FIBEROPTIC GmbHFET2025-06-11
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
04048551425695n.a.Karl Storz GmbH & Co. KGFET2024-12-20
04250480101704NASCHÖLLY FIBEROPTIC GmbHFET2024-12-03
04048551436271n.a.Karl Storz GmbH & Co. KGFET2024-11-28
04048551436240n.a.Karl Storz GmbH & Co. KGFET2024-10-18
07613327616682SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616729SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616743SPYSTRYKER CORPORATIONNWB2024-02-27
04250480112861NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480112878NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480112885NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113592NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113608NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113615NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113622NASCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113639EleVision™SCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113646EleVision™SCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113653EleVision™SCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113660EleVision™SCHÖLLY FIBEROPTIC GmbHFET2024-01-08
04250480113684TipVision™SCHÖLLY FIBEROPTIC GmbHFET2024-01-08