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

Name: FDA 510(k) clearance K922354
Creator: U.S. Food and Drug Administration
Published: 1992-07-30

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.. Device class: 1.

Clearance details

Applicant: Med Institute, Inc.
Product code: Code GCC
Device class: Class 1
Regulation: 21 CFR 878.4200
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

Download summary PDF View on FDA.gov ↗

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K902502 — BYRD STAINLESS STEEL DILATOR1990-08-07
K893480 — BYRD EXTRACTOR SET1989-06-23
K820865 — VAN-TEC FASCIAL DILATOR1982-05-05

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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.