STERILE PACKAGED POWER INSTRUMENT ACCESSORIES— 510(k) K911930

Name: FDA 510(k) clearance K911930
Creator: U.S. Food and Drug Administration
Published: 1991-07-02

Substantially Equivalent

United American Medical Co., Inc.

FDA 510(k) clearance K911930 for STERILE PACKAGED POWER INSTRUMENT ACCESSORIES, Substantially Equivalent on 1991-07-02. Applicant: United American Medical Co., Inc.. Device class: 1.

Clearance details

Applicant: United American Medical Co., Inc.
Product code: Code HWE
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1991-04-30
Decision date: 1991-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mc Minnville, TN, US

Download summary PDF View on FDA.gov ↗

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K930319 — OSTEON ADAPTOR/CRADLE1994-01-07
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Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.