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
K043500Substantially Equivalent

Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle

Innospine, Inc., Los Altos Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043500 is the FDA 510(k) clearance record for FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE, a class II device, cleared for Innospine, Inc. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list one 510(k) clearance for Innospine, Inc. As of , FDA records show one recall naming K043500.

Clearance record

Decision date
Received
(116 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
Innospine, Inc. 11240 Magdalena Rd., Los Altos Hills CA
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