PORGES URETERAL STENT— 510(k) K881744

Name: FDA 510(k) clearance K881744
Creator: U.S. Food and Drug Administration
Published: 1988-05-03

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K881744 for PORGES URETERAL STENT, Substantially Equivalent on 1988-05-03. Applicant: Bivona Medical Technologies. Device class: 2.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-22
Decision date: 1988-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

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K251890 — Disposable Ureteral Stents2026-02-20
K251469 — Endura Ureteral Stent and Stent Set2025-12-19
K243039 — Ureteral Stents (AF-D series)2025-06-18
K243830 — Disposable ureteral stent2025-05-14
K250824 — Percuflex Ureteral Stent +11 more2025-04-15

More clearances from Bivona Medical Technologies

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K952700 — SUPERSLICK1995-10-31
K942025 — BURGET NASAL STENT1995-10-27
K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES1994-10-27
K935053 — BIVONA NASAL TURBINATE STENT1994-07-01
K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE1993-10-06

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.