510(k) Report

510(k) · Cleared

Recalled · 2004

Drainage Stent

K834468510(k) TraditionalCleared Apr 20, 1984122-day reviewClass II21 CFR 876.5010Recalls 2

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

Microvasive · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Apr 20, 1984 after a 122-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 2 times.

Decided
Apr 20, 1984
Review
122 days
Class
Class II
Product code
FGE
Recalls
2
Predicates
0

18 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2010: 2 descendants cleared2019: 1 descendant cleared2020: 3 descendants cleared2014: 2 descendants cleared2022: 2 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant cleared19801990200020102020
  1. This deviceK834468 Drainage StentMicrovasive · 1984
  2. Descendant · cites it directly · 17 of its ownK965147 Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · Recalled
  3. Descendant · 2 generations on · 14 of its ownK101314 Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010
  4. Descendant · 3 generations on · 4 of its ownK133700 Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic…Boston Scientific Corporation · 2014 · Recalled
  5. Descendant · 3 generations on · 3 of its ownK193600 EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020
  6. Descendant · 3 generations on · 3 of its ownK140630 Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1997: 12010: 22014: 22019: 12020: 32022: 22023: 22024: 22025: 22026: 1
1997high 3 (2020) · low 0 (1998)2026

Most influential descendants

Showing 5 of 18 · See all
  • K965147Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp · 1997 · cites it directly17descendants
  • K101314Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp · 2010 · 2 generations on14descendants
  • K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery System and…Boston Scientific Corporation · 2014 · 3 generations on4descendants
  • K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd. · 2020 · 3 generations on3descendants
  • K140630Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K834468Drainage StentMicrovasive1984—
+1K965147Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp199723
+2K101314Advanix Biliary Stent with Naviflex RX Delivery SystemBoston Scientific Corp2010—
+3K133700Advanix Pancreatic Stent and Naviflex Rapid Exchange Pancreatic Delivery…Boston Scientific Corporation201413
+3K193600EndoGI Biliary Stent SystemEndogi Medical, Ltd.2020—
+3K140630Wallflex Biliary RX Stent SystemBoston Scientific20141

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
201020
201420
201910
202030
202220
202320
202420
202520
202610
FIG. 1 — Lineage of K834468, 1984–2026Source: 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), 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
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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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K965147Biliary Stent, Biliary Stent System, Biliary EndoprosthesisBoston Scientific Corp199717
K101786Advanix Double Pigtail Biliary StentBoston Scientific Corp20101

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 18, 2004Not classifiedZ-1103-04OtherMislabeled as to length; 5 cm length labeled as 10 cm.
Jun 18, 2004Not classifiedZ-1102-04OtherMislabeled as to length; 10 cm length labeled as 5 cm.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K965147 (Boston Scientific Corp, 1997) has gone furthest, with 17 descendants of its own.

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—

More from Microvasive

18 FDA decisions under this applicant name. See the company

  • K872771Low Profile GastrostomyMicrovasive · 1987
  • K870705Thermal CoagulatorMicrovasive · 1987
  • K861309Jejunal Feeding TubeMicrovasive · 1986
  • K861323Replacement Gastrostomy TubeMicrovasive · 198621 recalls
  • K860589Inflator/Deflator Piston SyringeMicrovasive · 1986

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https://510kreport.com/device/K834468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K834468: Drainage Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K834468

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