FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE— 510(k) K872597

Name: FDA 510(k) clearance K872597
Creator: U.S. Food and Drug Administration
Published: 1987-07-28

Substantially Equivalent

Dianon Systems, Inc.

FDA 510(k) clearance K872597 for FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE, Substantially Equivalent on 1987-07-28. Applicant: Dianon Systems, Inc.. Device class: 1.

Clearance details

Applicant: Dianon Systems, Inc.
Product code: Code DWO
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-07-02
Decision date: 1987-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stratford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWO

view all

K933364 — PROMED BIOPSY NEEDLE1994-02-15
K921418 — ULTRA-CORE BIOPSY NEEDLES1992-06-19
K913815 — AUTOMATED BIOPSY DEVICE, MODIFICATION1991-10-30
K890925 — MANAN BONE MARROW BIOPSY NEEDLE1989-04-11
K885145 — MEDSURG GREENE NEEDLE1989-03-14

More clearances from Dianon Systems, Inc.

view all

K882105 — CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM1988-07-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.