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510(k) K943697

TROCARS,CANNULAE,SHEATHS,OBTURATORS by Karl Storz Endoskop GmbH — Product Code ODB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
July 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Contamination Prevention Sheath
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To protect an endoscope from contamination by providing a barrier between the body and the endoscope.

Other clearances by Karl Storz Endoskop GmbH

  • K973068 — KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING (November 7, 1997)
  • K961702 — KSEA VAPORIZATION ELECTRODES (August 29, 1996)
  • K953368 — LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES (September 18, 1995)
  • K943713 — TORCARS,CANNULAE,SHEATHS,OBTURATORS (June 30, 1995)
  • K951995 — KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR (May 24, 1995)
  • K943053 — KSEA SEMM TISSUR PUNCH (March 21, 1995)
  • K943435 — CHOLANGIOGRAPHY SET (November 7, 1994)
  • K944823 — KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES (November 2, 1994)
  • K943904 — RIGID TELESCOPES (October 14, 1994)
  • K943816 — TROCARS,CANNULAE, SHEATHS (August 24, 1994)

Other clearances for product code ODB

  • K183171 — ScopeSeal Duodenoscope Protective Device (October 8, 2019)
  • K153698 — LumenR Tissue Retractor System (April 19, 2016)
  • K080550 — MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 (June 10, 2008)
  • K060475 — EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 (March 17, 2006)