510(k) Report

510(k) · Cleared

Cleared

Infra Vision Bougie Kit, Infra Vision Esophageal Kit

K960173510(k) TraditionalCleared Jun 27, 1996163-day reviewClass II21 CFR 876.5365

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gabriel Medical, Inc. · FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

Cleared on Jun 27, 1996 as substantially equivalent to K934084 (Bioenterics Corp., 1993) and 2 other predicates after a 163-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.

Decided
Jun 27, 1996
Review
163 days
Class
Class II
Product code
FAT
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K934084 (1993). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1999: 1 descendant cleared2013: 1 descendant clearedK934084 · Bioenterics Endolumina Illuminating Bougie · Bioenterics Corp. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K934084 · Bioenterics Endolumina Illuminating Bougie · Bioenterics Corp. · 19930
  1. Root · 1 generation backK934084 Bioenterics Endolumina Illuminating BougieBioenterics Corp. · 1993
  2. This deviceK960173 Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc. · 1996
  3. Descendant · cites it directly · 1 of its ownK983220 Stryker Infravision Esophageal KitStryker Endoscopy · 1999 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK130906 Endoflip CatheterCrospon, Ltd. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K983220Stryker Infravision Esophageal KitStryker Endoscopy · 1999 · cites it directly1descendant
  • K130906Endoflip CatheterCrospon, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934084Bioenterics Endolumina Illuminating BougieBioenterics Corp.1993—
0 (this device)K960173Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc.1996—
+1K983220Stryker Infravision Esophageal KitStryker Endoscopy19992
+2K130906Endoflip CatheterCrospon, Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201310
FIG. 1 — Lineage of K960173, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K934084Bioenterics Endolumina Illuminating Bougie
Summary page 1
…Dilator, Rectal Dilator Classification Name: Esophageal and Gastrointestinal Bougie Urological Bougie PREDICATE DEVICES BioEnterics Corp. EndoLumina Illuminated Bougie (K934084) Gabriel Medical Ureteral llluminator System II(K945088) InfraVision™ Imaging System(K945297). INTENDED USE The InfraVision™ Bo…
Bioenterics Corp.1993—
*K945088Gabriel Ureteral Illuminator System II
Summary page 1
…and Gastrointestinal Bougie Urological Bougie PREDICATE DEVICES BioEnterics Corp. EndoLumina Illuminated Bougie (K934084) Gabriel Medical Ureteral llluminator System II(K945088) InfraVision™ Imaging System(K945297). INTENDED USE The InfraVision™ Bougie is intended to aid in the identification of the eso…
Gabriel Medical, Inc.1995—
*K945297Infra Vision Imaging System
Summary page 1
…l Bougie PREDICATE DEVICES BioEnterics Corp. EndoLumina Illuminated Bougie (K934084) Gabriel Medical Ureteral llluminator System II(K945088) InfraVision™ Imaging System(K945297). INTENDED USE The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other s…
Gabriel Medical, Inc.19941

Also cleared against K934084: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983220Stryker Infravision Esophageal KitStryker Endoscopy19991

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K983220 (Stryker Endoscopy, 1999) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K934084.

How does its category compare?

All FAT devices

FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAT

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FAT

Too few FAT 510(k)s in any year since 2007 to give a median.

Recalls per year · FAT

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAT

2in 2025

2008: 12010: 52011: 22012: 32014: 12015: 32019: 12020: 22021: 22023: 12024: 32025: 2
2007high 5 (2010) · low 0 (2007)2025

MAUDE reports naming product code FAT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—10
20100—15
20110—02
20120—03
20130—00
20141—01
20150—03
20160—00
20170—00
20180—00
20190—01
20200—02
20210—02
20220—00
20230—01
20240—03
20250—02
20260—0—

What is it indicated for?

a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures;

b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and

c. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K934084

1 other device cites the same predicate.

  • K983220Stryker Infravision Esophageal KitStryker Endoscopy · 19992 recalls

More from Gabriel Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in FAT

The FAT category page

  • K133439Pilling Esophageal BougiesTeleflexmedical, Inc. · 2014
  • K983220Stryker Infravision Esophageal KitStryker Endoscopy · 19992 recalls
  • K972119Maloney Bouge (1210-XX)/Hurst Bougie (1212-XX)Medovations, Inc. · 1998
  • K901425Pyloric Balloon DilatorTelemed Systems, Inc. · 1990
  • K843186Eska Multistage Esophageal BougieDacomed Corp. · 1985

https://510kreport.com/device/K960173 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960173: Infra Vision Bougie Kit, Infra Vision Esophageal Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960173

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026