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510(k) K890722

ADG BONE BIOPSY SYSTEM by American Design Group, Inc. — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1989
Date Received
February 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by American Design Group, Inc.

  • K911717 — ADG INTRAMEDULLARY BONE PLUG - VENTED (September 4, 1991)
  • K902615 — ADG BONE PLUG (September 11, 1990)

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  • K953064 — BIOACCESS MARROW HARVEST SYSTEM (August 7, 1995)
  • K936207 — ENDO-NEEDLE INSTRUMENT (June 16, 1994)
  • K930160 — ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE (July 6, 1993)
  • K923872 — BONE MARROW BIOPSY SYSTEM (December 15, 1992)
  • K915572 — BECTON DICKINSON MODIFIED MENGHINI NEEDLE (February 3, 1992)
  • K904667 — NA NEEDLES (December 12, 1990)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)