510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862238Substantially Equivalent

Bivona Fome-Cuf Laser Endotracheal Tube

Bivona Medical Technologies, Gary IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862238 is the FDA 510(k) clearance record for BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE, a class II device, cleared for Bivona Medical Technologies on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 50 510(k) clearances for Bivona Medical Technologies, from to . As of , FDA records show no recalls naming K862238.

Clearance record

Decision date
Received
(125 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Bivona Medical Technologies 5700 W. 23rd Ave., Gary IN
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