ENDOSHEATH— 510(k) K990354

Substantially Equivalent

Vision-Sciences, Inc.

FDA 510(k) clearance K990354 for ENDOSHEATH, Substantially Equivalent on 1999-03-31. Applicant: Vision-Sciences, Inc..

Clearance details

Applicant: Vision-Sciences, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1999-02-05
Decision date: 1999-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick, MA, 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.