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510(k) K941506

URETERAL ILLUMINATOR by Apple Medical Corp. — Product Code FCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1994
Date Received
March 29, 1994
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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  • 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)
  • 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)