B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM— 510(k) K021344

Substantially Equivalent

Vision-Sciences, Inc.

FDA 510(k) clearance K021344 for B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM, Substantially Equivalent on 2002-05-24. Applicant: Vision-Sciences, Inc..

Clearance details

Applicant: Vision-Sciences, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2002-04-29
Decision date: 2002-05-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Ayer, MA, US

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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.