HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS— 510(k) K983385

Name: FDA 510(k) clearance K983385
Creator: U.S. Food and Drug Administration
Published: 1999-03-15

Substantially Equivalent

Hutchison Intl., Inc.

FDA 510(k) clearance K983385 for HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS, Substantially Equivalent on 1999-03-15. Applicant: Hutchison Intl., Inc.. Device class: Unclassified.

Clearance details

Applicant: Hutchison Intl., Inc.
Product code: Code LCJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1998-09-25
Decision date: 1999-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

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.