510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160121Substantially Equivalent

CorPath GRX System

Corindus, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160121 is the FDA 510(k) clearance record for CorPath GRX System, a class II device, cleared for Corindus, Inc. on under FDA product code DXX (System, Catheter Control, Steerable). FDA records list 9 510(k) clearances for Corindus, Inc., from to . As of , FDA records show no recalls naming K160121.

Clearance record

Decision date
Received
(282 days to decision)
Product code
DXX System, Catheter Control, Steerable
Regulation
21 CFR 870.1290
Device class
Class II
Review panel
Cardiovascular
Applicant
Corindus, Inc. 309 Waverley Oaks Rd., Suite 105, Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXX

Trailing 12 months
2 clearances under product code DXX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260