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Raypilot Hypocath 1

by Micropos Medical AB (Publ)

Raypilot Hypocath 1 (1004) is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Micropos Medical AB (Publ), cleared under FDA 510(k) K203722 on 2 Sep 2021 and listed in FDA GUDID since 4 Apr 2023 (UDI-DI 07350007951045), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K203722

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350007951045 UDI-DI Date4 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203722 Date2 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203722 decided 2 Sep 2021 Active
  • FDA GUDID UDI-DI 07350007951045 listed 4 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203722
  2. Listed FDA GUDID 07350007951045

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Raypilot Hypocath
Generic name
Radiation therapy lesion localization urethral catheter, procedural
Model / Ref / Catalog
1, 1004
Primary DI / UDI-DI
07350007951045
510(k) Number
FDA product code
IYE
GMDN term
Radiation therapy lesion localization urethral catheter, procedural
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Radiation therapy lesion localization urethral catheter, procedural

Cleared under the same submission (K203722)

and 7 more cleared under K203722

Similar devices

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

Other devices from Micropos Medical AB (Publ)

See all devices from Micropos Medical AB (Publ) →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)