SOFT TISSUE EXPANDER— 510(k) K923381

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K923381 for SOFT TISSUE EXPANDER, Substantially Equivalent on 1993-05-05. Applicant: Acufex Microsurgical, Inc..

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HWQ
Advisory panel: Orthopedic
Date received: 1992-07-09
Decision date: 1993-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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Adverse events under product code HWQ

product code HWQ

Injury: 137
Malfunction: 443
Total: 580

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.