PEREGRINE WET SET, MODEL PD400.00— 510(k) K990518

Substantially Equivalent

Peregrine Surgical , Ltd.

FDA 510(k) clearance K990518 for PEREGRINE WET SET, MODEL PD400.00, Substantially Equivalent on 1999-03-25. Applicant: Peregrine Surgical , Ltd..

Clearance details

Applicant: Peregrine Surgical , Ltd.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1999-02-18
Decision date: 1999-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doylestown, PA, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.