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510(k) K151243

STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] by Stryker Endoscopy — Product Code FCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2015
Date Received
May 11, 2015
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

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Other clearances for product code FCS

  • K061548 — STRYKER URETERAL ILLUMINATION SYSTEM IV (September 28, 2006)
  • K982542 — STRYKER URETERAL ILLUMINATOR SYSTEM III (September 22, 1998)
  • 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)