510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971411Substantially Equivalent

Disposable Silicone Epistaxis Catheter V-27030/Disposable Silicone Epistaxis Catheter Kit V-27030K

Bentec Medical, Inc., Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971411 is the FDA 510(k) clearance record for DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K, a class I device, cleared for Bentec Medical, Inc. on under FDA product code EMX (Balloon, Epistaxis). FDA records list 3 510(k) clearances for Bentec Medical, Inc., from to . As of , FDA records show no recalls naming K971411.

Clearance record

Decision date
Received
(48 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Bentec Medical, Inc. 4234 N. Fwy. Blvd., Sacramento CA
510(k) summary
Statement
Third party review
No

Clearances, product code EMX

Trailing 12 months

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

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