STERILIZER, STEAM, CASTLE 3000— 510(k) K770372

Name: FDA 510(k) clearance K770372
Creator: U.S. Food and Drug Administration
Published: 1977-04-05

Substantially Equivalent

Castle Co.

FDA 510(k) clearance K770372 for STERILIZER, STEAM, CASTLE 3000, Substantially Equivalent on 1977-04-05. Applicant: Castle Co.. Device class: 2.

Clearance details

Applicant: Castle Co.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 1977-02-25
Decision date: 1977-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K870975 — MODIFIED CASTLE POWERCLAVE1987-04-17
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K834048 — BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO1984-04-04
K833074 — CASTLE TEC-TEST S.M.A.R.T. PACK1983-11-07

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.