BAG SPIGOT— 510(k) K910673

Substantially Equivalent

Procedure Products, Inc.

FDA 510(k) clearance K910673 for BAG SPIGOT, Substantially Equivalent on 1991-04-24. Applicant: Procedure Products, Inc..

Clearance details

Applicant: Procedure Products, Inc.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1991-02-15
Decision date: 1991-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.