510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934367Substantially Equivalent

Pc-Mini

GE Healthcare, Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934367 is the FDA 510(k) clearance record for PC-MINI, a class I device, cleared for GE Medical Systems on under FDA product code JYD (Chisel, Mastoid). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K934367.

Clearance record

Decision date
Received
(62 days to decision)
Product code
JYD Chisel, Mastoid
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
GE Medical Systems P.O. Box 414, Milwaukee WI
510(k) summary
Summary
Third party review
No

Clearances, product code JYD

Trailing 12 months

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

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