BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET— 510(k) K922354

Substantially Equivalent

Med Institute, Inc.

FDA 510(k) clearance K922354 for BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET, Substantially Equivalent on 1992-07-30. Applicant: Med Institute, Inc..

Clearance details

Applicant: Med Institute, Inc.
Product code: Code GCC
Advisory panel: General, Plastic Surgery
Date received: 1992-05-19
Decision date: 1992-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

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Adverse events under product code GCC

product code GCC

Death: 3
Total: 3

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.