510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960173Substantially Equivalent

Infra Vision Bougie Kit, Infra Vision Esophageal Kit

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

K960173 is the FDA 510(k) clearance record for INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT, a class II device, cleared for Gabriel Medical, Inc. on under FDA product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology). FDA records list 5 510(k) clearances for Gabriel Medical, Inc., from to . As of , FDA records show no recalls naming K960173.

Clearance record

Decision date
Received
(163 days to decision)
Product code
FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Regulation
21 CFR 876.5365
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 FAT

Trailing 12 months

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

FDA records show no clearances under product code FAT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAT, 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