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510(k) K936207

ENDO-NEEDLE INSTRUMENT by Gerard Medical, Inc. — Product Code GDM

K936207 is an FDA 510(k) premarket notification submitted by Gerard Medical, Inc. for the device "ENDO-NEEDLE INSTRUMENT". The FDA issued a decision of Substantially Equivalent on June 16, 1994. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Gerard Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1994
Date Received
December 29, 1993
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 Gerard Medical, Inc.

  • K974533 — TRIMPORT (May 7, 1998)
  • K972555 — CATHETER TUNNELER (December 22, 1997)
  • K945060 — HERNIA MESH INTRODUCTION SYSTEM (March 2, 1995)

Other clearances for product code GDM

  • K071732 — MARROWMINER (September 24, 2007)
  • K971114 — BIOACCESS MARROW HARVEST SYSTEM (June 3, 1997)
  • K953082 — ILIAC CREST BONE MARROW ASPIRATION NEEDLE (September 22, 1995)
  • K953064 — BIOACCESS MARROW HARVEST SYSTEM (August 7, 1995)
  • 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)
  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)

FDA data resources