SMITH & NEPHEW IUR MORCELLATION SYSTEM— 510(k) K031787

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K031787 for SMITH & NEPHEW IUR MORCELLATION SYSTEM, Substantially Equivalent on 2003-12-02. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2003-06-10
Decision date: 2003-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.