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CorPath GRX System

by Corindus, Inc. 6 variants

510(k) K160121

CorPath GRX System is a Class II device made by Corindus, Inc., cleared under FDA 510(k) K160121 on 27 Oct 2016, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160121 Date27 Oct 2016ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DXX
Device class
Class II
Regulation
21 CFR Part 870.1290
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K160121

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K160121
UDI-DISize and differences
CorPath GRX Cassette 305
Corindus, Inc.
305 / 30500816280023055
Single use: yes
No longer on the market
CorPath GRX Control Console 301
Corindus, Inc.
301 / 30100816280023017
Single use: no
No longer on the market
CorPath GRX Drape, Control Console 311
Corindus, Inc.
311 / 31100816280023116
Single use: yes
No longer on the market
CorPath GRX Drape, Robotic Drive and Arm 309
Corindus, Inc.
309 / 30900816280023093
Single use: yes
No longer on the market
CorPath GRX Drive Gear 307
Corindus, Inc.
307 / 30700816280023079
Single use: yes
No longer on the market
CorPath GRX Extended Reach Arm 302
Corindus, Inc.
302 / 30200816280023024
Single use: no
No longer on the market

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. →