510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960201Substantially Equivalent

G.e. Sterile Breast Biopsy/localization Tray

GE Healthcare, Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960201 is the FDA 510(k) clearance record for G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY, a class II device, cleared for GE Medical Systems on under FDA product code FRG (Wrap, Sterilization). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K960201.

Clearance record

Decision date
Received
(36 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
GE Medical Systems 1247 Flordia Ave., Palm Harbor FL
510(k) summary
Statement
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to November 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260