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510(k) K862749

LS9000 SUCTION BIOPSY NEEDLE by Engineering, Inc. — Product Code GDM

K862749 is an FDA 510(k) premarket notification submitted by Engineering, Inc. for the device "LS9000 SUCTION BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on September 15, 1986. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Engineering, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1986
Date Received
July 21, 1986
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 Engineering, Inc.

  • K881521 — MODIFIED SERVO SYRINGE (May 31, 1988)
  • K862476 — LS3000 CANNULA UTERINE SUCTION (July 18, 1986)
  • K854359 — LM2000A SURGICAL SUCTION MONITOR (March 3, 1986)
  • K854844 — LS1000 SURGICAL ASPIRATOR II (February 12, 1986)

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)
  • 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)
  • K903748 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V (October 31, 1990)

FDA data resources