SURGICAL INSTRUMENTS— 510(k) K801819

Substantially Equivalent

Robert I. Chien & Assoc., Inc.

FDA 510(k) clearance K801819 for SURGICAL INSTRUMENTS, Substantially Equivalent on 1980-08-20. Applicant: Robert I. Chien & Assoc., Inc..

Clearance details

Applicant: Robert I. Chien & Assoc., Inc.
Product code: Code HXD
Advisory panel: General, Plastic Surgery
Date received: 1980-07-31
Decision date: 1980-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HXD

product code HXD

Malfunction: 660
Total: 660

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.