510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211887Substantially Equivalent

Personal Kinetigraph (PKG) System Gen 2 Plus

GKC Manufacturing Pty Ltd, Melbourne, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211887 is the FDA 510(k) clearance record for Personal Kinetigraph (PKG) System Gen 2 Plus, a class II device, cleared for Gkc Manufacturing Pty, Ltd. on under FDA product code GYD (Transducer, Tremor). FDA records list 3 510(k) clearances for Gkc Manufacturing Pty, Ltd., from to . As of , FDA records show no recalls naming K211887.

Clearance record

Decision date
Received
(263 days to decision)
Product code
GYD Transducer, Tremor
Regulation
21 CFR 882.1950
Device class
Class II
Review panel
Neurology
Applicant
Gkc Manufacturing Pty, Ltd. Level 9, 31 Queen St., Melbourne, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GYD

Trailing 12 months
3 clearances under product code GYD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GYD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260