510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061210Substantially Equivalent

Functional Anaesthetic Discography (Fad) Catheter System, Model D01a ; Introducer Needle, Model D01b

Medtronic, Inc., Sunnyvale CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061210 is the FDA 510(k) clearance record for FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B, a class II device, cleared for Kyphon, Inc. on under FDA product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K061210.

Clearance record

Decision date
Received
(57 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
Kyphon, Inc. 1221 Crossman Ave., Sunnyvale 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260