510(k) Report

510(k) · Decided

Recalled · 2002

Modification to Precise Nitinol Stent Transhepatic Biliary System

K012993510(k) SpecialDecided Oct 5, 200129-day reviewClass II21 CFR 876.5010Recalls 1

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

Cordis Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Oct 5, 2001 as substantially equivalent to K010445 (Cordis Corp., 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 25 later devices descend from it. It has been recalled once.

Decided
Oct 5, 2001
Review
29 days
Class
Class II
Product code
FGE
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K010445 (2001). 25 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 7 descendants cleared2002: 2 descendants cleared2005: 1 descendant cleared2004: 2 descendants cleared2006: 2 descendants cleared2008: 4 descendants cleared2013: 2 descendants cleared2010: 2 descendants cleared2012: 2 descendants cleared2011: 1 descendant clearedK010445 · Precise Nitinol Stent Transhepatic Billary System · Cordis Corp. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K010445 · Precise Nitinol Stent Transhepatic Billary System · Cordis Corp. · 20010+5
  1. Root · 1 generation backK010445 Precise Nitinol Stent Transhepatic Billary SystemCordis Corp. · 2001
  2. This deviceK012993 Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2001
  3. Descendant · cites it directly · 24 of its ownK021898 Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK031777 Modeification to: Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003 · Recalled
  5. Descendant · 2 generations on · 9 of its ownK032457 Modification to Smart Control Nitinol Stent Transhepatic Biliary…Cordis Corp. · 2003
  6. Descendant · 3 generations on · 6 of its ownK060557 Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc. · 2006
  7. Descendant · 4 generations on · 5 of its ownK071646 Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery…Idev Technologies, Inc. · 2008

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2002: 22003: 72004: 22005: 12006: 22008: 42010: 22011: 12012: 22013: 2
2002high 7 (2003) · low 0 (2007)2026

Most influential descendants

Showing 5 of 25 · See all
  • K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2002 · cites it directly24descendants
  • K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · 2 generations on10descendants
  • K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 2003 · 2 generations on9descendants
  • K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc. · 2006 · 3 generations on6descendants
  • K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…Idev Technologies, Inc. · 2008 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010445Precise Nitinol Stent Transhepatic Billary SystemCordis Corp.2001—
0 (this device)K012993Modification to Precise Nitinol Stent Transhepatic Biliary SystemCordis Corp.2001—
+1K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20021
+2K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20033
+2K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2003—
+3K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery…Idev Technologies, Inc.2006—
+4K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter…Idev Technologies, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200370
200420
200510
200620
200840
201020
201110
201220
201320
FIG. 1 — Lineage of K012993, 2001–2013Source: 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 FGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FGE device

  1. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K010445Precise Nitinol Stent Transhepatic Billary System
Summary page 1
…anshepatic Biliary Stent Biliary System (6F) Name of The device is substantially equivalent to: Predicate e Precise™ Nitinol Stent Transhepatic Biliary System (510(k) # K010445 — Devices ‘May 16, 2001). Classification Class II. Performance Performance standards have not been established by the FDA under…
Cordis Corp.2001—

Also cleared against K010445: 3 other devices →

What descends from it? (25)

See all 25

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.200224
K024303Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemEdwards Lifesciences, LLC20034
K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp.20030

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 7, 2002Not classifiedZ-0323-03OtherField complaints of marker band spacing being out of spec.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K021898 (Cordis Corp., 2002) has gone furthest, with 24 descendants of its own.
  • 3 other devices also cite its predicate K010445.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGE

7in 2025

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
2007high 93 (2008) · low 0 (2014)2026

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

Adverse event reports per year · FGE

1,923in 2025

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, 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
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

What is it indicated for?

The Precise™ Nitinol Stent Transhepatic Biliary System (6F) is indicated for

use in the palliation of malignant neoplasms in the biliary tree.

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 K010445

3 other devices cite the same predicate.

  • K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBCordis Corp. · 20082 recalls
  • K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp. · 20031 recall
  • K024303Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemEdwards Lifesciences, LLC · 2003

More from Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

Recent decisions in FGE

The FGE category page

  • K254179Drainage CatheterCanyon Medical, Inc. · 2026
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
  • K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019…Hangzhou AGS MedTech Co., Ltd. · 2026
  • K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd. · 2026

https://510kreport.com/device/K012993 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012993: Modification to Precise Nitinol Stent Transhepatic Biliary System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012993

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026