Home / 510(k) Clearances / K982542

510(k) K982542

STRYKER URETERAL ILLUMINATOR SYSTEM III by Stryker Endoscopy — Product Code FCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1998
Date Received
July 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class
Class II
Regulation Number
876.4020
Review Panel
GU
Submission Type

Other clearances by Stryker Endoscopy

  • K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with (February 18, 2026)
  • K260108 — L12 LED Light Source with AIM (February 12, 2026)
  • K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (January 13, 2026)
  • K253888 — MOLLI 2 System (December 31, 2025)
  • K252010 — SPY Laparoscope (July 24, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K250544 — Knotilus+ Biocomposite Knotless Anchor (May 23, 2025)
  • K250528 — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (May 21, 2025)
  • K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (August 15, 2024)
  • K240407 — ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-S (March 7, 2024)

Other clearances for product code FCS

  • K151243 — STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral (August 20, 2015)
  • K061548 — STRYKER URETERAL ILLUMINATION SYSTEM IV (September 28, 2006)
  • K943801 — URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (August 15, 1995)
  • K945088 — GABRIEL URETERAL ILLUMINATOR SYSTEM II (February 7, 1995)
  • K941506 — URETERAL ILLUMINATOR (October 5, 1994)
  • K940019 — GABRIEL URETERAL ILLUMINATOR SYSTEM (May 2, 1994)
  • K923436 — ILLUMINATED URETERAL CATHETER (March 5, 1993)
  • K874680 — LASEGUIDE 600A, 600B, 400A, AND 400B (March 23, 1988)
  • K880071 — SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE (March 22, 1988)