PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES— 510(k) K881927

Substantially Equivalent

Advanced Surgical Products, Inc.

FDA 510(k) clearance K881927 for PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES, Substantially Equivalent on 1988-05-25. Applicant: Advanced Surgical Products, Inc..

Clearance details

Applicant: Advanced Surgical Products, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1988-05-09
Decision date: 1988-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterfield, MO, US

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.