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510(k) K001362

KARL STORZ 3D VIDEO SYSTEM by Karl Storz Imaging, Inc. — Product Code GCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2000
Date Received
April 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Other clearances by Karl Storz Imaging, Inc.

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  • K994090 — KARL STORZ AUTOCLAVABLE CAMERA HEAD (February 4, 2000)
  • K990154 — KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM (June 1, 1999)
  • K974391 — KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM (January 30, 1998)
  • K973252 — KARL STORZ DIRECT COUPLED CAMERA HEAD (November 24, 1997)
  • K963333 — OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) (October 22, 1996)
  • K950862 — KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL FORMAT) COLOR TELEVI (May 24, 1995)
  • K950974 — KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TE (May 11, 1995)
  • K950975 — KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY (May 11, 1995)

Other clearances for product code GCI

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  • K933515 — BOOTY ENDOSCOPE WARMER (October 27, 1993)
  • K930302 — BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)
  • K922123 — AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (February 1, 1993)
  • K920139 — GLEESON CLOT-BUSTER (April 15, 1992)
  • K915762 — POOLE TIP SUCTION PROBE (March 13, 1992)
  • K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (October 30, 1991)
  • K911829 — ENDOSTAPLE (August 28, 1991)