510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170298Substantially Equivalent

Liberator Beacon Tip Locking Stylet

Cook Incorporated, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170298 is the FDA 510(k) clearance record for Liberator Beacon Tip Locking Stylet, a class II device, cleared for Cook Incorporated on under FDA product code DRB (Stylet, Catheter). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K170298.

Clearance record

Decision date
Received
(260 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Cook Incorporated 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRB

Trailing 12 months

FDA records hold no clearances under product code DRB in the trailing twelve months.

FDA records show no clearances under product code DRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260