STAT IM 5000 CASSETTE AUTOCLAVE— 510(k) K962179

Name: FDA 510(k) clearance K962179
Creator: U.S. Food and Drug Administration
Published: 1997-01-13

Substantially Equivalent

Scican

FDA 510(k) clearance K962179 for STAT IM 5000 CASSETTE AUTOCLAVE, Substantially Equivalent on 1997-01-13. Applicant: Scican. Device class: 2.

Clearance details

Applicant: Scican
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 1996-06-06
Decision date: 1997-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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K964691 — TCB TEMPORARY CROWN AND BRIDGE MATERIAL1997-02-04
K944036 — STERIMASTER AUTOCLAVE1996-10-02

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.