510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K844696Substantially Equivalent

Trogide

Carmel Medical Devices, Carmel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844696 is the FDA 510(k) clearance record for TROGIDE, a class II device, cleared for Carmel Medical Devices on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list one 510(k) clearance for Carmel Medical Devices. As of , FDA records show no recalls naming K844696.

Clearance record

Decision date
Received
(91 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Carmel Medical Devices P.O. Box 222892, Carmel CA
Third party review
No

Clearances, product code BTR

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