Home / 510(k) Clearances / K925741

510(k) K925741

CLARUS ENDOSCOPIC HOOK KNIFE by Clarus Medical Systems, Inc. — Product Code HLX

K925741 is an FDA 510(k) premarket notification submitted by Clarus Medical Systems, Inc. for the device "CLARUS ENDOSCOPIC HOOK KNIFE". The FDA issued a decision of Substantially Equivalent on August 24, 1993. The device falls under product code HLX (Photostimulator, Ac-Powered), a Class II device regulated under 21 CFR 886.1630. Clarus Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1993
Date Received
November 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photostimulator, Ac-Powered
Device Class
Class II
Regulation Number
886.1630
Review Panel
OP
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 HLX

  • K003442 — MODIFICATION TO EDI VERIS SYSTEM (May 4, 2001)
  • K983983 — EDI VERIS SYSTEM (February 3, 1999)
  • K914393 — RETINA TESTER (March 2, 1992)
  • K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1] (October 25, 1991)
  • K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR (February 5, 1988)
  • K853812 — PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (November 1, 1985)
  • K833446 — DOWNING SPECTRAL ILLUMINATOR (March 12, 1984)
  • K832762 — MILLER/NADLER GLARE TESTER (September 29, 1983)
  • K831231 — LED GOGGLES (May 16, 1983)
  • K830770 — CONTRAST SENSITIVITY EQUIPMENT (April 28, 1983)

FDA data resources