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510(k) K874680

LASEGUIDE 600A, 600B, 400A, AND 400B by Laser Peripherals, LLC — Product Code FCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1988
Date Received
November 13, 1987
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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  • 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)
  • K880071 — SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE (March 22, 1988)