SPIVE NEEDLE SYSTEM, MODIFICATION— 510(k) K904013

Substantially Equivalent

Pascall Medical Corp.

FDA 510(k) clearance K904013 for SPIVE NEEDLE SYSTEM, MODIFICATION, Substantially Equivalent on 1990-10-01. Applicant: Pascall Medical Corp..

Clearance details

Applicant: Pascall Medical Corp.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1990-08-29
Decision date: 1990-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.