Home / 510(k) Clearances / K981491

510(k) K981491

UROSURGE FILASTENT URETERAL STENT by Urosurge, Inc. — Product Code FAD

K981491 is an FDA 510(k) premarket notification submitted by Urosurge, Inc. for the device "UROSURGE FILASTENT URETERAL STENT". The FDA issued a decision of Substantially Equivalent on May 29, 1998. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Urosurge, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1998
Date Received
April 27, 1998
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 Urosurge, Inc.

  • DEN000002 — UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE (February 9, 2000)
  • K992391 — UROSURGE SPIRALFLO URETERAL STENT (August 18, 1999)
  • K981489 — UROSURGE SPIRASTENT PLUS URETERAL STENT (May 29, 1998)

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