510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861050Substantially Equivalent

Biopsy Adapter H4222w

General Electric Co., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861050 is the FDA 510(k) clearance record for BIOPSY ADAPTER H4222W, a class I device, cleared for General Electric Co. on under FDA product code GDF (Guide, Needle, Surgical). FDA records list 256 510(k) clearances for General Electric Co., from to . As of , FDA records show no recalls naming K861050.

Clearance record

Decision date
Received
(14 days to decision)
Product code
GDF Guide, Needle, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
General Electric Co. P.O. Box 414, Milwaukee WI
Third party review
No

Clearances, product code GDF

Trailing 12 months

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

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