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510(k) K980588

CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 by Clarus Medical Systems, Inc. — Product Code GAD

K980588 is an FDA 510(k) premarket notification submitted by Clarus Medical Systems, Inc. for the device "CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000". The FDA issued a decision of Substantially Equivalent on August 18, 1998. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Clarus Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1998
Date Received
February 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Clarus Medical Systems, Inc.

  • 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)
  • K941188 — CLARUS NEURO ENDOSCOPE (MODEL 2230) (April 25, 1995)

Other clearances for product code GAD

  • K152538 — JRP Wound Spreader (April 13, 2016)
  • K151104 — OTELO LL (January 6, 2016)
  • K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES (October 4, 2013)
  • K071775 — DASH (August 7, 2007)
  • K050256 — APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (April 26, 2005)
  • K043602 — QUADRANT RETRACTOR SYSTEM (February 23, 2005)
  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEM (September 20, 1996)
  • K943875 — VILLALTA RETRACTOR (November 9, 1994)
  • K942002 — RETRACTOR (May 17, 1994)

FDA data resources