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510(k) K943904

RIGID TELESCOPES by Karl Storz Endoskop GmbH — Product Code ENZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
August 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Telescope, Laryngeal-Bronchial
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • K943697 — TROCARS,CANNULAE,SHEATHS,OBTURATORS (September 14, 1994)
  • K943816 — TROCARS,CANNULAE, SHEATHS (August 24, 1994)

Other clearances for product code ENZ

  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K790845 — DUALUME LARYNGEAL EXAMINATION TELESCOPE (July 24, 1979)