510(k) Report

FDA applicant

Gabriel Medical, Inc.

North Attleboro, MA5 decisions1990–19961 recall

FDA records 5 decisions for Gabriel Medical, Inc. (North Attleboro, MA) from 1990 to 1996: 5 510(k) clearances. Most are in product codes FCS (Light, Catheter, Fiberoptic, Glass, Ureteral) and FAT (Bougie, Esophageal, And Gastrointestinal…). Its devices cite 3 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Gabriel Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gabriel Medical, Inc. since 2007.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Gabriel Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gabriel Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FCSLight, Catheter, Fiberoptic, Glass, Ureteral2decisions
  • FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology1decision
  • GCJLaparoscope, General & Plastic Surgery1decision
  • DSFRecorder, Paper Chart1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K945088Gabriel Ureteral Illuminator System IIGabriel Medical, Inc. · 19952cite it
  • K960173Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc. · 19961cites it
  • K945297Infra Vision Imaging SystemGabriel Medical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K960173Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc. · 1996
  • K945088Gabriel Ureteral Illuminator System IIGabriel Medical, Inc. · 1995
  • K945297Infra Vision Imaging SystemGabriel Medical, Inc. · 19941 recall
  • K940019Gabriel Ureteral Illuminator SystemGabriel Medical, Inc. · 1994
  • K901385Gabriel Medical CLS Thermal RecorderGabriel Medical, Inc. · 1990

All 5 as Gabriel Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K945297InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker…Sep 29, 2010

Other applicant names beginning “Gabriel”

FDA records each applicant name separately; these may or may not be the same firm.

Gabriel Ent. 2