MENTOR UNISTENT URETERAL STENT SET— 510(k) K875038

Name: FDA 510(k) clearance K875038
Creator: U.S. Food and Drug Administration
Published: 1988-03-03

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K875038 for MENTOR UNISTENT URETERAL STENT SET, Substantially Equivalent on 1988-03-03. Applicant: Mentor Corp.. Device class: 2.

Clearance details

Applicant: Mentor Corp.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1987-12-07
Decision date: 1988-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

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K243830 — Disposable ureteral stent2025-05-14
K250824 — Percuflex Ureteral Stent +11 more2025-04-15

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K053414 — MENTOR NOVASILK MESH2005-12-27
K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER2005-06-03
K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT2004-11-09
K040959 — MENTOR GENESIS PENILE PROSTHESIS2004-10-29

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.