CorPath GRX System: FDA 510(k) K173288, Corindus, Inc.

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK173288	Date15 Feb 2018Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K173288

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K173288
FDA product code: DXX

Device class: Class II
Regulation: 21 CFR Part 870.1290
Advisory committee: Cardiovascular
FDA decision: SESE Substantially Equivalent

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

CorPath GRX System K160121 27 Oct 2016 FDA record · FDA summary
CorPath 200 System K152999 18 Mar 2016 FDA record · FDA summary

Cited by

CorPath GRX System K202275 11 Dec 2020 FDA record · FDA summary
CorPath GRX System K180517 29 Mar 2018 FDA record · FDA summary

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

Devices cleared under K173288

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 K173288
		UDI-DI	Size and differences
CorPath GRX Cassette 305 Corindus, Inc.	305 / 305	00816280023055	Single use: yes	No longer on the market
CorPath GRX Control Console 301 Corindus, Inc.	301 / 301	00816280023017	Single use: no	No longer on the market
CorPath GRX Drape, Control Console 311 Corindus, Inc.	311 / 311	00816280023116	Single use: yes	No longer on the market
CorPath GRX Drape, Robotic Drive and Arm 309 Corindus, Inc.	309 / 309	00816280023093	Single use: yes	No longer on the market
CorPath GRX Drive Gear 307 Corindus, Inc.	307 / 307	00816280023079	Single use: yes	No longer on the market
CorPath GRX Extended Reach Arm 302 Corindus, Inc.	302 / 302	00816280023024	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.

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