# K961446: AQ Hydrophilic Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: May 28, 1996 after 42 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905289 (1991). 1 ancestor in all.
14 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905289: Surgitek (R) Lubri-Flex (TM) Ureteral Stent, Medical Engineering Corp. (1991) Summary page 1.
- (no number) Slipcoat™ Stent: named in the summary without a submission number
- (no number) Hydro-Plus™: named in the summary without a submission number

## Most influential descendants
- K151051: Universa Soft Ureteral Stents and Stent Sets (2016), 11 descendants of its own
- K161236: Universa Firm Ureteral Stents and Stent Sets (2017), 5 descendants of its own
- K213444: RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (2022), 2 descendants of its own
- K173734: RocaJJ Soft Stents (2018), 1 descendant of its own
- K162104: C-Flex Ureteral Stent Set (2017), 1 descendant of its own

## Recalls of this device
- Jan 4, 2019 · Class II · Z-0977-2020: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
- Oct 18, 2010 · Not classified · Z-0852-2011: The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.
- Nov 10, 2008 · Not classified · Z-0980-2009: "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could r
- Jul 31, 2008 · Not classified · Z-0842-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0845-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0851-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0844-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0846-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0848-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0852-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0853-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0840-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0841-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0843-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0847-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0839-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0849-2009: The bond may break where the two materials meet, resulting in separation of the stent.
- Jul 31, 2008 · Not classified · Z-0850-2009: The bond may break where the two materials meet, resulting in separation of the stent.

## Indications for use
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder.

Source page: https://510kreport.com/device/K961446
Methodology: https://510kreport.com/methodology