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510(k) K872597

FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE by Dianon Systems, Inc. — Product Code DWO

K872597 is an FDA 510(k) premarket notification submitted by Dianon Systems, Inc. for the device "FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE". The FDA issued a decision of Substantially Equivalent on July 28, 1987. The device falls under product code DWO (Needle, Biopsy, Cardiovascular), a Class I device regulated under 21 CFR 878.4800. Dianon Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1987
Date Received
July 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Biopsy, Cardiovascular
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Dianon Systems, Inc.

  • K882105 — CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM (July 11, 1988)

Other clearances for product code DWO

  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K921418 — ULTRA-CORE BIOPSY NEEDLES (June 19, 1992)
  • K913815 — AUTOMATED BIOPSY DEVICE, MODIFICATION (October 30, 1991)
  • K890925 — MANAN BONE MARROW BIOPSY NEEDLE (April 11, 1989)
  • K885145 — MEDSURG GREENE NEEDLE (March 14, 1989)
  • K885149 — NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE (January 26, 1989)
  • K882013 — SOFT TISSUE BIOPSY DEVICE (June 15, 1988)
  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K853312 — ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (September 12, 1985)
  • K820269 — RNG SERIES ULTRASOUND NEEDLE/CATH. GDS (March 23, 1982)

FDA data resources