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510(k) K190576

WalterLorenz Surgical Assist Arm Scope Holder by Biomet Microfixation — Product Code OCV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2019
Date Received
March 6, 2019
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.

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  • K162974 — Biomet Microfixation RibFix Blu Thoracic Fixation System (December 9, 2016)
  • K163007 — Biomet Microfixation SternaLock 360 Sternal Closure System (November 23, 2016)
  • K161896 — Biomet Microfixation Sternal Closure System (August 2, 2016)

Other clearances for product code OCV

  • K240506 — KARL STORZ Holders (October 22, 2024)
  • K232405 — ENDOFIX EXO (April 25, 2024)
  • 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)
  • K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE (May 5, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)