TROCARS,CANNULAE, SHEATHS— 510(k) K943816

Name: FDA 510(k) clearance K943816
Creator: U.S. Food and Drug Administration
Published: 1994-08-24

Substantially Equivalent

Karl Storz Endoskop GmbH

FDA 510(k) clearance K943816 for TROCARS,CANNULAE, SHEATHS, Substantially Equivalent on 1994-08-24. Applicant: Karl Storz Endoskop GmbH. Device class: 2.

Clearance details

Applicant: Karl Storz Endoskop GmbH
Product code: Code EOB
Device class: Class 2
Regulation: 21 CFR 874.4760
Advisory panel: Ear, Nose, Throat
Date received: 1994-08-05
Decision date: 1994-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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Recent devices under product code EOB

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More clearances from Karl Storz Endoskop GmbH

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K973068 — KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING1997-11-07
K961702 — KSEA VAPORIZATION ELECTRODES1996-08-29
K953368 — LUER, JACKSON TRACHEA TUBES, LUER SPEAKING TRACHEA TUBES1995-09-18
K943713 — TORCARS,CANNULAE,SHEATHS,OBTURATORS1995-06-30
K951995 — KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR1995-05-24

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.