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510(k) K872353

SURGITEK INFUSION STENT SYSTEM* by Surgitek — Product Code FAD

K872353 is an FDA 510(k) premarket notification submitted by Surgitek for the device "SURGITEK INFUSION STENT SYSTEM*". The FDA issued a decision of Substantially Equivalent on September 16, 1987. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Surgitek has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1987
Date Received
June 18, 1987
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 Surgitek

  • K946296 — QUADRA-COIL URETERAL STENT (March 6, 1995)
  • K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM (February 7, 1995)
  • K943491 — RIGHT ANGLE UROLOGIC LASER FIBER (August 5, 1994)
  • K941952 — SURGITEK INFUSER (May 24, 1994)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K933260 — HELICAL STONE/FLATWIRE STONE BASKETS (January 11, 1994)
  • K930733 — URETERAL STENT (July 23, 1993)
  • K930483 — URETERAL CATHETER (July 16, 1993)
  • K926344 — HYDROPHILIC COATED GUIDEWIRE (March 5, 1993)
  • K920451 — ENDOTEK ULTRA SYSTEM (September 17, 1992)

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