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510(k) K943816

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1994
Date Received
August 5, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
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)
  • K943904 — RIGID TELESCOPES (October 14, 1994)
  • K943697 — TROCARS,CANNULAE,SHEATHS,OBTURATORS (September 14, 1994)

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  • K234096 — MonoStereo (September 19, 2024)
  • K232435 — Rhinolaryngoscope system (April 26, 2024)
  • K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507. (August 3, 2023)
  • K222587 — PatCom Distal Chip Endoscope (July 28, 2023)
  • K230536 — Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (June 14, 2023)
  • K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (December 28, 2022)
  • K221581 — Single-Use Flexible Rhinolaryngoscope (November 18, 2022)