510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983964Substantially Equivalent

Batch #6060 Conductive Gel

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

K983964 is the FDA 510(k) clearance record for BATCH #6060 CONDUCTIVE GEL, a class II device, cleared for Skylark Device Co., Ltd. on under FDA product code GYB (Media, Electroconductive). FDA records list 20 510(k) clearances for Skylark Device Co., Ltd., from to . As of , FDA records show no recalls naming K983964.

Clearance record

Decision date
Received
(33 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Skylark Device Co., Ltd. 34 Chung Shan N. Rd.,, Taipei, TW
510(k) summary
Statement
Third party review
No

Clearances, product code GYB

Trailing 12 months

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

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