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510(k) K973504

UROSURGE UROSTENT by Princeton Regulatory Assoc. — Product Code FAD

K973504 is an FDA 510(k) premarket notification submitted by Princeton Regulatory Assoc. for the device "UROSURGE UROSTENT". The FDA issued a decision of Substantially Equivalent on January 30, 1998. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Princeton Regulatory Assoc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
September 16, 1997
Clearance Type
Traditional
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

Other clearances by Princeton Regulatory Assoc.

  • K965136 — UROSURGE UROTHERM FLUID WARMING SYSTEM (October 16, 1998)
  • K972158 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES (February 20, 1998)
  • K962770 — UROSURGE ACUTRAINER (August 1, 1996)

Other clearances for product code FAD

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

FDA data resources