510(k) Report

510(k) · Cleared

Cleared

Pre-View Cholangiography Clamp

K973621510(k) TraditionalCleared Dec 17, 199785-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

Nashville Surgical Instruments · GBZ Catheter, Cholangiography

Cleared on Dec 17, 1997 as substantially equivalent to K942450 (Ethicon Endo-Surgery, Inc., 1994) after an 85-day review. Its family tree reaches back 1 generation to 1994.

Decided
Dec 17, 1997
Review
85 days
Class
Class I
Product code
GBZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K942450 (1994). No later device cites it as a predicate yet.

K942450 · Endopath · Ethicon Endo-Surgery, Inc. · 199419901992199419961998
K942450 · Endopath · Ethicon Endo-Surgery, Inc. · 19940
  1. Root · 1 generation backK942450 EndopathEthicon Endo-Surgery, Inc. · 1994
  2. This deviceK973621 Pre-View Cholangiography ClampNashville Surgical Instruments · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K942450EndopathEthicon Endo-Surgery, Inc.1994—
0 (this device)K973621Pre-View Cholangiography ClampNashville Surgical Instruments1997—
FIG. 1 — Lineage of K973621, 1994–1997Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 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? (1)

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
*K942450Endopath
Summary page 1
…al equivalence summary to anyone requesting it from the Agency. NEW DEVICE NAME: PRE-VIEW* Cholangiography Clamp PREDICATE DEVICE NAME: ENDOPATH* Cholangiography Clamp K 942450 510(k) "SE" DECISION-MAKING PROCESS INDICATIONS STATEMENT: YES. The New Device and the ENDOPATH* Cholangiography Clamp Predica…
Ethicon Endo-Surgery, Inc.1994—

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.

What does this lineage say?

  • Its one ancestor has no 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—

What is it indicated for?

The Pre-View Cholangiography Clamp is intended to

provide a method of laparoscopic cholangiography.

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

More from Nashville Surgical Instruments

2 FDA decisions under this applicant name. See the company

  • K081366Kumar T-Anchors Hernia SetNashville Surgical Instruments · 2008

Recent decisions in GBZ

The GBZ category page

  • K944790Flexible Laparoscopic Cholangiography CatheterApplied Medical Resources · 1994
  • 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/K973621 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973621: Pre-View Cholangiography Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973621

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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