FDA.reportPublic FDA data

ULTRASONIC PROBE

Primary DI
04953170467301
Brand
ULTRASONIC PROBE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
UM-S20-17S
Catalog number
N5386440
Published
2025-09-18
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
EOQBronchoscope (Flexible Or Rigid)
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250762000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250762000ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)Olympus Medical Systems Corporation2025-07-11ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170467301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170467301049531704673014953170467301

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic ultrasound imaging transducerA flexible, ultrasound imaging transducer assembly designed to be to be inserted through the working channel of an appropriate flexible endoscope and positioned within the gastrointestinal, respiratory or urinary tract, (i.e., application is not specific to any particular anatomy) to transmit a signal/data to another device for display. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920684PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920899PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920929PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826920950PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926389PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926419PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926426PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926464PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926808PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926815PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926822PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926839PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926846PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926877PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926884PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926891PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926976PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25
04580826926983PENTAX MedicalPENTAX MEDICAL CORPORATIONEOQ2026-08-25