FDA.reportPublic FDA data

Raypilot Hypocath

Primary DI
07350007951045
Brand
Raypilot Hypocath
Company
Micropos Medical AB (Publ)
Model
1
Catalog number
1004
Device description
Raypilot Hypocath is inteded for real time localization of a target during radiation therapy for men with prostate cancer. It is a Foley catheter with a transmitter inserted in one of the lumens. The catheter ensures urine drainage through the duration of the radiation therapy.
Published
2023-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203722000RayPilot SystemMicropos Medical AB2021-09-02IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350007951540PackageGS110In Commercial Distribution
07350007951045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350007951540073500079515407350007951540
07350007951045073500079510457350007951045

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy lesion localization urethral catheter, proceduralA flexible tube with an electrically-powered localization marker [e.g., electromagnetic (EM) transmitter] at its distal end intended to be introduced into the prostatic urethra, to create an identifying mark, for the alignment and monitoring of a patient's tumour/lesion position relative to the isocenter of a radiation therapy system during a therapeutic procedure. It may allow urinary drainage or incorporate a balloon for stabilization. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+46317608005info@micropos.se

Regulatory Flags#

DUNS number
350533316
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350007952202Raypilot Receiver120202025-03-12
07350007956026Raypilot System Cable160022025-03-12
07350007951052Raypilot Viewcath110052023-04-04
07350007952219Raypilot Extension Plate120212023-04-04
07350007953049Raypilot Software130042023-04-04
07350007954053Raypilot Quality Control Kit140052023-04-04
07350007954060Raypilot Transmitter Tester140062023-04-04
07350007954077Raypilot Table Displacement Meter140072023-04-04
07350007956019Raypilot Transmitter Cable160012023-04-04
07350007956033Raypilot Power Box160032023-04-04
07350007956040Raypilot Matching Network160042023-04-04

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Primary DI, Brand, Company table
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00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
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00841439115305MultiFix 2QfixIYE2026-06-04
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00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
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