DIALY-NATE SET & DIALY-NATE CATHETER— 510(k) K872221

Name: FDA 510(k) clearance K872221
Creator: U.S. Food and Drug Administration
Published: 1987-10-13

Substantially Equivalent

Gesco Intl., Inc.

FDA 510(k) clearance K872221 for DIALY-NATE SET & DIALY-NATE CATHETER, Substantially Equivalent on 1987-10-13. Applicant: Gesco Intl., Inc.. Device class: 2.

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code FKO
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 1987-06-09
Decision date: 1987-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FKO

view all

K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS1998-06-26
K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR1998-02-27
K910787 — TITANIUM CONNECTOR (2 PART)1991-08-15
K885037 — AMUKIN 50% - AIRSPRAY(R)1990-10-19
K874650 — PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)1987-12-09

More clearances from Gesco Intl., Inc.

view all

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.