510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133597Substantially Equivalent

Ciaglia Percutaneous Tracheostomy Introducer Set/tray, Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set/tray

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

K133597 is the FDA 510(k) clearance record for CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, a class II device, cleared for Cook, Inc. on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show one recall naming K133597.

Clearance record

Decision date
Received
(147 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Cook, Inc. 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOH

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