DeviceClearance

EAGLE CENTURY STEAM STERILIZER— 510(k) K964332

Substantially Equivalent

Amsco Intl., Inc.

FDA 510(k) clearance K964332 for EAGLE CENTURY STEAM STERILIZER, Substantially Equivalent on 1998-06-01. Applicant: Amsco Intl., Inc.. Device class: 2.

Clearance details

Applicant
Amsco Intl., Inc.
Product code
Code FLE
Device class
Class 2
Regulation
21 CFR 880.6880
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Erie, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FLE

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Adverse events under product code FLE

product code FLE
Malfunction
444
Total
444

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K964332

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964332.

Data sourced from openFDA. This site is unofficial and independent of the FDA.