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510(k) K913815

AUTOMATED BIOPSY DEVICE, MODIFICATION by Hart Enterprises, Inc. — Product Code DWO

K913815 is an FDA 510(k) premarket notification submitted by Hart Enterprises, Inc. for the device "AUTOMATED BIOPSY DEVICE, MODIFICATION". The FDA issued a decision of Substantially Equivalent on October 30, 1991. The device falls under product code DWO (Needle, Biopsy, Cardiovascular), a Class I device regulated under 21 CFR 878.4800. Hart Enterprises, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1991
Date Received
August 26, 1991
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 Hart Enterprises, Inc.

  • K921683 — PENCIL POINT SPINAL NEEDLE (August 26, 1993)
  • K885149 — NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE (January 26, 1989)
  • K881730 — BREAST LOCALIZATION NEEDLES (May 13, 1988)

Other clearances for product code DWO

  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K921418 — ULTRA-CORE BIOPSY NEEDLES (June 19, 1992)
  • 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)
  • K872597 — FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE (July 28, 1987)
  • K853312 — ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (September 12, 1985)
  • K820269 — RNG SERIES ULTRASOUND NEEDLE/CATH. GDS (March 23, 1982)

FDA data resources