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510(k) K960068

SH-1 SURGICAL HOLDER FOR TELESCOPE by Olympus America, Inc. — Product Code OCV

K960068 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "SH-1 SURGICAL HOLDER FOR TELESCOPE". The FDA issued a decision of Substantially Equivalent on May 5, 1997. The device falls under product code OCV (Endoscope Holder), a Class II device regulated under 21 CFR 876.1500. Olympus America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1997
Date Received
January 5, 1996
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 Olympus America, Inc.

  • K111788 — ENDOEYE HD II (January 13, 2012)
  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K073490 — OLYMPUS IGG REAGENT (February 11, 2008)
  • K073487 — OLYMPUS IGM REAGENT (February 11, 2008)
  • K073489 — OLYMPUS IGA REAGENT (February 11, 2008)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K061499 — OSFERION (January 26, 2007)
  • K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (November 29, 2006)
  • K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (October 5, 2006)

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)
  • K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (May 23, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)

FDA data resources