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510(k) K940019

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

K940019 is an FDA 510(k) premarket notification submitted by Gabriel Medical, Inc. for the device "GABRIEL URETERAL ILLUMINATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 1994. 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
May 2, 1994
Date Received
January 3, 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)
  • K945088 — GABRIEL URETERAL ILLUMINATOR SYSTEM II (February 7, 1995)
  • K945297 — INFRA VISION IMAGING SYSTEM (December 20, 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)
  • K945088 — GABRIEL URETERAL ILLUMINATOR SYSTEM II (February 7, 1995)
  • K941506 — URETERAL ILLUMINATOR (October 5, 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