CONSENSUS(TM) BIPOLAR SYSTEM— 510(k) K922560

Name: FDA 510(k) clearance K922560
Creator: U.S. Food and Drug Administration
Published: 1992-09-11

Substantially Equivalent

U.S. Medical Products, Inc.

FDA 510(k) clearance K922560 for CONSENSUS(TM) BIPOLAR SYSTEM, Substantially Equivalent on 1992-09-11. Applicant: U.S. Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: U.S. Medical Products, Inc.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 1992-05-29
Decision date: 1992-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.