510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871964Substantially Equivalent

Siegen Neuroscope Seeg for Evoked Response Stimu.

Siegen Corp., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871964 is the FDA 510(k) clearance record for SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU., a class II device, cleared for Siegen Corp. on under FDA product code GWF (Stimulator, Electrical, Evoked Response). FDA records list 6 510(k) clearances for Siegen Corp., from to . As of , FDA records show no recalls naming K871964.

Clearance record

Decision date
Received
(134 days to decision)
Product code
GWF Stimulator, Electrical, Evoked Response
Regulation
21 CFR 882.1870
Device class
Class II
Review panel
Neurology
Applicant
Siegen Corp. 538 Oakmead Pkwy., Sunnyvale CA
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