510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071482Substantially Equivalent

Stryker RF Multi-Lesion Generator, Model 0406-900-000

Synergetics Inc, O' Fallon MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071482 is the FDA 510(k) clearance record for STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000, a class II device, cleared for Synergetics, Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 18 510(k) clearances for Synergetics, Inc., from to . As of , FDA records show one recall naming K071482.

Clearance record

Decision date
Received
(204 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Synergetics, Inc. 3845 Corporate Centre Dr., O' Fallon MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXD

Trailing 12 months

FDA records hold no clearances under product code GXD in the trailing twelve months.

FDA records show no clearances under product code GXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, 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