510(k) Report

510(k) · Cleared

Cleared

Flexible Laparoscopic Cholangiography Catheter

K944790510(k) TraditionalCleared Nov 29, 199462-day reviewClass I21 CFR 878.4200

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

Applied Medical Resources · GBZ Catheter, Cholangiography

Cleared on Nov 29, 1994 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 29, 1994
Review
62 days
Class
Class I
Product code
GBZ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K944790Source: FDA 510(k) database · How lineage is built

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

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

Planning a device in GBZ? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All GBZ devices

GBZ Catheter, Cholangiography: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBZ

FDA has decided no GBZ device since 2007.

Median 510(k) review, days · GBZ

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

Recalls per year · GBZ

1in 2023

2008: 72016: 82018: 12023: 12026 (partial year): 3
2007high 8 (2016) · low 0 (2007)2026

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

Adverse event reports per year · GBZ

6in 2025

2007: 62008: 302009: 212010: 122011: 162012: 122013: 92014: 162015: 122016: 82017: 212018: 512019: 122020: 112021: 72022: 72023: 52024: 32025: 6
2007high 51 (2018) · low 3 (2024)2025

MAUDE reports naming product code GBZ, 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—06
20080—730
20090—021
20100—012
20110—016
20120—012
20130—09
20140—016
20150—012
20160—88
20170—021
20180—151
20190—012
20200—011
20210—07
20220—07
20230—15
20240—03
20250—06
20260—3—

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58 FDA decisions under this applicant name. See the company

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Recent decisions in GBZ

The GBZ category page

  • K973621Pre-View Cholangiography ClampNashville Surgical Instruments · 1997
  • K942450EndopathEthicon Endo-Surgery, Inc. · 1994
  • K932228Microvasive Insurg Chloangiographic CatheterBoston Scientific Corp · 1993
  • K926217Terumo Angiographic Catheter for Laporoscopic UseTerumo Medical Corp. · 1993
  • K924212Stryker Endoscopy Cholangiogram KitStryker Corp. · 1993

https://510kreport.com/device/K944790 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944790: Flexible Laparoscopic Cholangiography Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944790

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026