510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K034012Substantially Equivalent

Smith & Nephew RF Denervation Probes & RF Cannulae

Smith & Nephew, Inc., Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K034012 is the FDA 510(k) clearance record for SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code GXI (Probe, Radiofrequency Lesion). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show 3 recalls naming K034012.

Clearance record

Decision date
Received
(83 days to decision)
Product code
GXI Probe, Radiofrequency Lesion
Regulation
21 CFR 882.4725
Device class
Class II
Review panel
Neurology
Applicant
Smith & Nephew, Inc. 150 Minuteman Rd., Andover MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXI

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