SINUSCOPE— 510(k) K940317

Substantially Equivalent

Stephen Chakoff, Inc.

FDA 510(k) clearance K940317 for SINUSCOPE, Substantially Equivalent on 1995-05-24. Applicant: Stephen Chakoff, Inc..

Clearance details

Applicant: Stephen Chakoff, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1994-01-24
Decision date: 1995-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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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.