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510(k) K945088

GABRIEL URETERAL ILLUMINATOR SYSTEM II by Gabriel Medical, Inc. — Product Code FCS

K945088 is an FDA 510(k) premarket notification submitted by Gabriel Medical, Inc. for the device "GABRIEL URETERAL ILLUMINATOR SYSTEM II". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral), a Class II device regulated under 21 CFR 876.4020. Gabriel Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
October 17, 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

Other clearances by Gabriel Medical, Inc.

  • K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT (June 27, 1996)
  • K945297 — INFRA VISION IMAGING SYSTEM (December 20, 1994)
  • K940019 — GABRIEL URETERAL ILLUMINATOR SYSTEM (May 2, 1994)
  • K901385 — GABRIEL MEDICAL CLS THERMAL RECORDER (May 9, 1990)

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)
  • K982542 — STRYKER URETERAL ILLUMINATOR SYSTEM III (September 22, 1998)
  • K943801 — URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (August 15, 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)

FDA data resources