Home / 510(k) Clearances / K163068

510(k) K163068

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent by Q Urological Corporation — Product Code FAD

K163068 is an FDA 510(k) premarket notification submitted by Q Urological Corporation for the device "pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent". The FDA issued a decision of Substantially Equivalent on Dec 22, 2016. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Q Urological Corporation has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 22, 2016
Date Received
Nov 2, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type
510(k)

Other clearances by Q Urological Corporation

  • K172289 — pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent (Oct 4, 2017)
  • K082805 — PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX (Jan 20, 2010)

Other clearances for product code FAD

  • K251890 — Disposable Ureteral Stents (Feb 20, 2026)
  • K251469 — Endura™ Ureteral Stent and Stent Set (Dec 19, 2025)
  • K243039 — Ureteral Stents (AF-D series) (Jun 18, 2025)
  • K243830 — Disposable ureteral stent (May 14, 2025)
  • K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus… (Apr 15, 2025)
  • K232920 — RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent… (Mar 22, 2024)
  • K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima… (Nov 10, 2022)
  • K213185 — ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone… (Jun 8, 2022)
  • K213444 — RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent… (Mar 17, 2022)
  • K213186 — NovoFlow Reinforced Ureteral Stent (Feb 16, 2022)

FDA data resources