510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K922657Substantially Equivalent

Aga Trach Ties

Aga Medical Products, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922657 is the FDA 510(k) clearance record for AGA TRACH TIES, a class I device, cleared for Aga Medical Products, Inc. on under FDA product code CBH (Device, Fixation, Tracheal Tube). FDA records list 2 510(k) clearances for Aga Medical Products, Inc., from to . As of , FDA records show no recalls naming K922657.

Clearance record

Decision date
Received
(29 days to decision)
Product code
CBH Device, Fixation, Tracheal Tube
Regulation
21 CFR 868.5770
Device class
Class I
Review panel
Anesthesiology
Applicant
Aga Medical Products, Inc. 903 Dolphin Dr., Malvern PA
510(k) summary
Statement
Third party review
No

Clearances, product code CBH

Trailing 12 months

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

FDA records show no clearances under product code CBH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBH, 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