SES-2012 AUTOMATIC STEAM STERILIZER— 510(k) K924596

Name: FDA 510(k) clearance K924596
Creator: U.S. Food and Drug Administration
Published: 1994-04-15

Substantially Equivalent

Porter Instrument Co., Inc.

FDA 510(k) clearance K924596 for SES-2012 AUTOMATIC STEAM STERILIZER, Substantially Equivalent on 1994-04-15. Applicant: Porter Instrument Co., Inc.. Device class: 2.

Clearance details

Applicant: Porter Instrument Co., Inc.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 1992-09-11
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatfield, PA, US

Download summary PDF View on FDA.gov ↗

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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.