510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K130346Substantially Equivalent

Synergy Focus Desktop Version; Synergy Focus Laptop Version

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

K130346 is the FDA 510(k) clearance record for SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION, a class II device, cleared for Natus Neurology Incorporated on under FDA product code GWF (Stimulator, Electrical, Evoked Response). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K130346.

Clearance record

Decision date
Received
(80 days to decision)
Product code
GWF Stimulator, Electrical, Evoked Response
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Applicant
Natus Neurology Incorporated 1850 Deming Way, Middleton WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWF

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