510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092973Substantially Equivalent

Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar Needle

Bionen S.A.S., Carmel IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092973 is the FDA 510(k) clearance record for DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE, a class II device, cleared for Bionen S.A.S. on under FDA product code IKT (Electrode, Needle, Diagnostic Electromyograph). FDA records list one 510(k) clearance for Bionen S.A.S. As of , FDA records show no recalls naming K092973.

Clearance record

Decision date
Received
(377 days to decision)
Product code
IKT Electrode, Needle, Diagnostic Electromyograph
Regulation
21 CFR 890.1385
Device class
Class II
Review panel
Physical Medicine
Applicant
Bionen S.A.S. 11460 N.Meridian St.,, Carmel IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IKT

Trailing 12 months
1 clearance under product code IKT in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IKT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260