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VRP Probe VRP-20

by Koven Technology, Inc.

VRP Probe VRP-20 is a Class II device made by Koven Technology, Inc., cleared under FDA 510(k) K935994 on 11 May 1995 and listed in FDA GUDID since 22 Jun 2016 (UDI-DI 00894912002630), active as of 22 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 22 Oct 2026

Documents

510(k) K935994

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00894912002630 UDI-DI Date22 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK935994 Date11 May 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K935994 decided 11 May 1995 Active
  • FDA GUDID UDI-DI 00894912002630 listed 22 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K935994
  2. Listed FDA GUDID 00894912002630

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VRP Probe
Generic name
Invasive vascular ultrasound system probe
Model / Ref / Catalog
VRP-20
Primary DI / UDI-DI
00894912002630
510(k) Number
FDA product code
JAF, ITX
GMDN term
Invasive vascular ultrasound system probe
Device class
Class II
Regulation number
892.1540, 892.1570
GUDID distribution status
In Commercial Distribution
Sterilisation method
Hydrogen Peroxide

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Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (12, all answered No)