NORTEC URETERAL STENT— 510(k) K910691

Name: FDA 510(k) clearance K910691
Creator: U.S. Food and Drug Administration
Published: 1991-08-15

Substantially Equivalent

North American Sterilization & Packaging Co.

FDA 510(k) clearance K910691 for NORTEC URETERAL STENT, Substantially Equivalent on 1991-08-15. Applicant: North American Sterilization & Packaging Co.. Device class: 2.

Clearance details

Applicant: North American Sterilization & Packaging Co.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1991-02-19
Decision date: 1991-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparta, NJ, US

Download summary PDF View on FDA.gov ↗

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K925588 — NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI1993-12-03
K925593 — NORTEC STERILE WATER FOR DEVICE IRRIGATION1993-12-03

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.