Home / 510(k) Clearances / K971584

510(k) K971584

CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) by Clarus Medical Systems, Inc. — Product Code OCV

K971584 is an FDA 510(k) premarket notification submitted by Clarus Medical Systems, Inc. for the device "CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code OCV (Endoscope Holder), 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 23, 1997
Date Received
April 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Holder
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To hold endoscope in a desired position during procedures.

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)
  • 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 OCV

  • K240506 — KARL STORZ Holders (October 22, 2024)
  • K232405 — ENDOFIX EXO (April 25, 2024)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K102179 — ENVIEW (TM) (December 2, 2010)
  • K093616 — V. MUELLER CAMERA CONTROLLER WITH STORAGE CART (December 23, 2009)
  • K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (August 17, 1999)
  • K990334 — KSEA ENDOSCOPE HOLDER (March 22, 1999)
  • K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE (May 5, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)

FDA data resources