SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015— 510(k) K904479

Substantially Equivalent

Percutaneous Technologies

FDA 510(k) clearance K904479 for SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015, Substantially Equivalent on 1990-11-02. Applicant: Percutaneous Technologies.

Clearance details

Applicant: Percutaneous Technologies
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1990-10-02
Decision date: 1990-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut, CA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.