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
K163435Substantially Equivalent

Entellus Medical Reinforced Anesthesia Needle

Entellus Medical, Inc., Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163435 is the FDA 510(k) clearance record for Entellus Medical Reinforced Anesthesia Needle, a class II device, cleared for Entellus Medical, Inc. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 27 510(k) clearances for Entellus Medical, Inc., from to . As of , FDA records show no recalls naming K163435.

Clearance record

Decision date
Received
(119 days to decision)
Product code
BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Regulation
21 CFR 868.5150
Device class
Class II
Review panel
Anesthesiology
Applicant
Entellus Medical, Inc. 3600 Holly Ln. N., Suite 40, Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSP

Trailing 12 months

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

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