XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM— 510(k) K971592

Name: FDA 510(k) clearance K971592
Creator: U.S. Food and Drug Administration
Published: 1998-02-26

Substantially Equivalent

The Silcraft Corp.

FDA 510(k) clearance K971592 for XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM, Substantially Equivalent on 1998-02-26. Applicant: The Silcraft Corp.. Device class: 2.

Clearance details

Applicant: The Silcraft Corp.
Product code: Code ILJ
Device class: Class 2
Regulation: 21 CFR 890.5100
Advisory panel: Physical Medicine
Date received: 1997-05-01
Decision date: 1998-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K971593 — SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT1998-02-26

Adverse events under product code ILJ

product code ILJ

Death: 4
Total: 4

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.