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510(k) K831071

UNIVERSAL INSTRU. SET FOR NEUROVASCULAR by Prothia USA, Inc. — Product Code GZX

K831071 is an FDA 510(k) premarket notification submitted by Prothia USA, Inc. for the device "UNIVERSAL INSTRU. SET FOR NEUROVASCULAR". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code GZX (Instrument, Microsurgical), a Class I device regulated under 21 CFR 882.4525. Prothia USA, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 4, 1983
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 Prothia USA, Inc.

  • K830993 — AMPLIGREFFE (May 3, 1983)
  • K823581 — ELPHA 500 (March 24, 1983)
  • K830058 — MYOGRAPH 2000 (March 7, 1983)
  • K823583 — MYOTEST NERVE STIMULATOR (December 30, 1982)

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)
  • K873933 — RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (December 17, 1987)
  • 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)

FDA data resources