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CorPath GRX Control Console 301

by Corindus, Inc.

CorPath GRX Control Console 301 is a Class II device made by Corindus, Inc., cleared under FDA 510(k) K202275 on 11 Dec 2020 (2 earlier submissions) and listed in FDA GUDID since 20 Jan 2017 (UDI-DI 00816280023017), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202275 Date11 Dec 2020DecidedStatusActive
United StatesGUDID listing Number00816280023017 UDI-DI Date20 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202275 decided 11 Dec 2020 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00816280023017 listed 20 Jan 2017 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K160121
  2. Listed FDA GUDID 00816280023017
  3. Cleared FDA 510(k) K173288
  4. Cleared FDA 510(k) K202275

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CorPath GRX Control Console
Generic name
Cardiac mapping system workstation
Model / Ref / Catalog
301
Primary DI / UDI-DI
00816280023017
FDA product code
DXX
GMDN term
Cardiac mapping system workstation
Device class
Class II
Regulation number
870.1290
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Cardiac mapping system workstation

Similar devices

Other devices filed under FDA product code DXX (System, Catheter Control, Steerable).

Other devices from Corindus, Inc.

See all devices from Corindus, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)