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510(k) K885145

MEDSURG GREENE NEEDLE by Medsurg Industries, Inc. — Product Code DWO

K885145 is an FDA 510(k) premarket notification submitted by Medsurg Industries, Inc. for the device "MEDSURG GREENE NEEDLE". The FDA issued a decision of Substantially Equivalent on March 14, 1989. The device falls under product code DWO (Needle, Biopsy, Cardiovascular), a Class I device regulated under 21 CFR 878.4800. Medsurg Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1989
Date Received
December 15, 1988
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 Medsurg Industries, Inc.

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K940175 — MEDSURG STERILE O.R. TOWELS (May 26, 1994)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K925558 — INFILTUBE (March 4, 1994)
  • K934971 — STERILE LAPAROTOMY SPONGES (February 7, 1994)
  • K920421 — MEDSURG MARSHMALLOW TRAY (December 13, 1993)
  • K920838 — MEDSURG CIRCUMCISION TRAY (October 15, 1993)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K914037 — MEDSURG O.R. PROCEDURE TRAY (June 22, 1993)
  • K914036 — MEDSURG LAPAROSCOPY TRAY (March 18, 1992)

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)
  • 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