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510(k) K932169

MICROSURGICAL INSTRUMENTS by American Russian Medical Services, Inc. — Product Code GZX

K932169 is an FDA 510(k) premarket notification submitted by American Russian Medical Services, Inc. for the device "MICROSURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on July 20, 1993. The device falls under product code GZX (Instrument, Microsurgical), a Class I device regulated under 21 CFR 882.4525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1993
Date Received
May 5, 1993
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 for product code GZX

  • 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)
  • K873933 — RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (December 17, 1987)
  • K862971 — MICRA MICROSURGICAL INSTRUMENTS (August 25, 1986)
  • K853161 — THE VICKERS STANDARD MICROSURGERY SET (November 7, 1985)
  • K853179 — VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (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