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510(k) K971455

CLARUS MODEL 5197 SIGHTLITE by Clarus Medical Systems, Inc. — Product Code FTI

K971455 is an FDA 510(k) premarket notification submitted by Clarus Medical Systems, Inc. for the device "CLARUS MODEL 5197 SIGHTLITE". The FDA issued a decision of Substantially Equivalent on May 20, 1997. The device falls under product code FTI (Lamp, Endoscope, Incandescent), a Class II device regulated under 21 CFR 876.1500. Clarus Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1997
Date Received
April 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Endoscope, Incandescent
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
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)
  • 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 FTI

  • K914397 — OXFORD OPTRONIX MPM 3S (November 16, 1992)

FDA data resources