510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945088Substantially Equivalent

Gabriel Ureteral Illuminator System II

Gabriel Medical, Inc., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945088 is the FDA 510(k) clearance record for GABRIEL URETERAL ILLUMINATOR SYSTEM II, a class II device, cleared for Gabriel Medical, Inc. on under FDA product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral). FDA records list 5 510(k) clearances for Gabriel Medical, Inc., from to . As of , FDA records show no recalls naming K945088.

Clearance record

Decision date
Received
(113 days to decision)
Product code
FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Regulation
21 CFR 876.4020
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gabriel Medical, Inc. Attn: Mary M. Mcnamara, North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code FCS

Trailing 12 months

FDA records hold no clearances under product code FCS in the trailing twelve months.

FDA records show no clearances under product code FCS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260