510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K872597Substantially Equivalent

Fine Needle Aspiration Biopsy System-Prostate

Dianon Systems, Inc., Stratford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872597 is the FDA 510(k) clearance record for FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE, a class I device, cleared for Dianon Systems, Inc. on under FDA product code DWO (Needle, Biopsy, Cardiovascular). FDA records list 2 510(k) clearances for Dianon Systems, Inc., from to . As of , FDA records show no recalls naming K872597.

Clearance record

Decision date
Received
(26 days to decision)
Product code
DWO Needle, Biopsy, Cardiovascular
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Dianon Systems, Inc. 200 Watson Blvd., Stratford CT
Third party review
No

Clearances, product code DWO

Trailing 12 months

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

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