510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K090955Substantially Equivalent

Smith & Nephew RF Cannulate

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

K090955 is the FDA 510(k) clearance record for SMITH & NEPHEW RF CANNULATE, 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 one recall naming K090955.

Clearance record

Decision date
Received
(101 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. 1450 Brooks Rd., Memphis TN
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