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510(k) K992006

NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 by Integra Neurocare, LLC — Product Code OCV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1999
Date Received
June 15, 1999
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 Integra Neurocare, LLC

  • K002392 — VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V (November 2, 2000)
  • K981246 — BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850- (May 26, 1999)
  • K973525 — MAURICE WORLDWIDE SHUNT SYSTEM (December 16, 1997)
  • K972994 — EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS (November 3, 1997)
  • K972261 — RIVETTI-LEVINSON INSTRALUMINAL SHUNT (September 15, 1997)
  • K971617 — ENDOSCOPIC VENTRICULAR CATHETER (July 31, 1997)
  • K970983 — PERITONEAL/CARDIAC CATHETER (June 13, 1997)
  • K970658 — LUMBAR DRAINAGE ACCESSORY KIT (May 19, 1997)
  • K964371 — SHUNT TAP WITH ICP MONITORING ACCESS PORT (January 31, 1997)
  • K961859 — NOVUS STANDARD AND PEDIATRIC VALVES (December 16, 1996)

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)
  • K990334 — KSEA ENDOSCOPE HOLDER (March 22, 1999)
  • K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (May 23, 1997)
  • K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE (May 5, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)