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510(k) K926048

CLARUS ENDOSCOPIC BALL PROBE by Clarus Medical Systems, Inc. — Product Code GZX

K926048 is an FDA 510(k) premarket notification submitted by Clarus Medical Systems, Inc. for the device "CLARUS ENDOSCOPIC BALL PROBE". The FDA issued a decision of Substantially Equivalent on April 7, 1993. The device falls under product code GZX (Instrument, Microsurgical), a Class I device regulated under 21 CFR 882.4525. Clarus Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1993
Date Received
December 1, 1992
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 Clarus Medical Systems, Inc.

  • K980588 — CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (August 18, 1998)
  • K974579 — PERCSCOPE MODEL 2600 (February 18, 1998)
  • K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (May 23, 1997)
  • K971455 — CLARUS MODEL 5197 SIGHTLITE (May 20, 1997)
  • K960915 — CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX (December 24, 1996)
  • K962255 — CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) (September 11, 1996)
  • K955598 — CLARUS SPINEPEN MODEL 2126 (February 6, 1996)
  • K953685 — INSTRUMENT SCOPE (October 12, 1995)
  • K945633 — NEURO CHANNEL ENDOSCOPE MODEL 2232 (September 19, 1995)
  • K945296 — CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 (July 14, 1995)

Other clearances for product code GZX

  • K932169 — MICROSURGICAL INSTRUMENTS (July 20, 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)
  • 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