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510(k) K873933

RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM by Downs Surgical , Ltd. — Product Code GZX

K873933 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM". The FDA issued a decision of Substantially Equivalent on December 17, 1987. The device falls under product code GZX (Instrument, Microsurgical), a Class I device regulated under 21 CFR 882.4525. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1987
Date Received
September 25, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Microsurgical
Device Class
Class I
Regulation Number
882.4525
Review Panel
NE
Submission Type

Other clearances by Downs Surgical , Ltd.

  • 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)
  • K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E (October 31, 1990)
  • K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U (October 31, 1990)
  • K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM (October 22, 1990)
  • K900612 — SHEPPERD TREPHINE SET (GS-501-30-V) (October 22, 1990)
  • K900613 — SHEPPERD SHELTER TUBE COMPLETE & DRILL (October 22, 1990)
  • K900609 — SHEPPERD STRAIGHT AND CURVED NEEDLES (October 22, 1990)
  • K900611 — SHEPPERD DILATATION TUBE SET (GS-501-20-H) (October 22, 1990)
  • K900616 — SHEPPERD CUTTING FORCEPS (October 22, 1990)

Other clearances for product code GZX

  • K932169 — MICROSURGICAL INSTRUMENTS (July 20, 1993)
  • K926048 — CLARUS ENDOSCOPIC BALL PROBE (April 7, 1993)
  • K911932 — J105 JAMES SURGICAL SYSTEM I/A PACK (August 26, 1991)
  • K890216 — MICROSURGICAL KERATOME (February 16, 1989)
  • K873934 — RANGE OF CROCODILE ACTION INSTRUMENTS (December 17, 1987)
  • K862971 — MICRA MICROSURGICAL INSTRUMENTS (August 25, 1986)
  • K853179 — VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (November 7, 1985)
  • K853161 — THE VICKERS STANDARD MICROSURGERY SET (November 7, 1985)
  • K853180 — VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED (October 28, 1985)
  • K853181 — VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED (October 28, 1985)

FDA data resources