Universa Soft Ureteral Stents and Stent Sets— 510(k) K151051
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K151051 for Universa Soft Ureteral Stents and Stent Sets, Substantially Equivalent on 2016-01-11. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- Product code
- Code FAD
- Device class
- Class 2
- Regulation
- 21 CFR 876.4620
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, IN, US
Recent devices under product code FAD
view allMore clearances from Cook Incorporated
view allAdverse events under product code FAD
product code FAD- Death
- 2
- Injury
- 858
- Malfunction
- 2,651
- Other
- 1
- Total
- 3,512
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K151051
K-number listed on FDA's recall record- Z-2971-2020 — Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
- Z-0978-2020 — Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151051.
Data sourced from openFDA. This site is unofficial and independent of the FDA.