CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE— 510(k) K983878

Name: FDA 510(k) clearance K983878
Creator: U.S. Food and Drug Administration
Published: 1999-01-29

Substantially Equivalent

E. Benson Hood Laboratories, Inc.

FDA 510(k) clearance K983878 for CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE, Substantially Equivalent on 1999-01-29. Applicant: E. Benson Hood Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: E. Benson Hood Laboratories, Inc.
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 1998-11-02
Decision date: 1999-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pembroke, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.