510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912643Substantially Equivalent

Electrode

Skylark Device Co., Ltd., Taipei, Taiwan, R.O.C., TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912643 is the FDA 510(k) clearance record for ELECTRODE, a class II device, cleared for Skylark Device Co., Ltd. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 20 510(k) clearances for Skylark Device Co., Ltd., from to . As of , FDA records show no recalls naming K912643.

Clearance record

Decision date
Received
(245 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Skylark Device Co., Ltd. 12 Floor 34, Sec. 3 Chung Shan, Taipei, Taiwan, R.O.C., TW
510(k) summary
Statement
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260