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510(k) K882073

SPINAL NEEDLE by Karlin Technology, Inc. — Product Code GDM

K882073 is an FDA 510(k) premarket notification submitted by Karlin Technology, Inc. for the device "SPINAL NEEDLE". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Karlin Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
May 17, 1988
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 Karlin Technology, Inc.

  • K903969 — SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET (September 5, 1990)
  • K893203 — BONE SCREW (April 4, 1990)
  • K893201 — BONE PLATE (April 4, 1990)
  • K882525 — SPINAL MICROKNIFE (September 22, 1988)
  • K882519 — X-RAY MARKER (August 9, 1988)
  • K882520 — SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS (July 18, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K882077 — MICRODISCECTOMY CURRETTES (June 17, 1988)
  • K882069 — SPINAL DISTRACTORS, SPANNERS (June 17, 1988)
  • K882072 — ORTHOPAEDIC AND SPINAL RING CURRETTES (June 17, 1988)

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)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)

FDA data resources