MODIFIED USE OF PULL-APART INTRODUCER SET— 510(k) K871730

Name: FDA 510(k) clearance K871730
Creator: U.S. Food and Drug Administration
Published: 1987-05-18

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K871730 for MODIFIED USE OF PULL-APART INTRODUCER SET, Substantially Equivalent on 1987-05-18. Applicant: Quinton, Inc.. Device class: 2.

Clearance details

Applicant: Quinton, Inc.
Product code: Code FKO
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1987-05-05
Decision date: 1987-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FKO

product code FKO

Other: 1
Total: 1

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.