510(k) · Cleared
Recalled · Class II · 2023GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creganna Medical Aslo Business AS Cregganna Tactx Medical · DYB Introducer, Catheter
Cleared on Jul 21, 2016 as substantially equivalent to K142829 (Cook Incorporated, 2015) after a 293-day review. Its family tree reaches back 6 generations to 1993. 1 of the 14 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 21, 2016
- Review
- 293 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924607 (1993). 7 ancestors in all. 6 later devices descend from it, 1 citing it directly. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 5 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 4 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 3 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 2 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- 1 generation backK142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor…Cook Incorporated · 2015 · Recalled (Class I)
- This deviceK152913 GORE TIPS Set, GORE TIPS Sheath, GORE TIPS NeedleCreganna Medical Aslo Business AS Cregganna Tactx Medical · 2016
- Descendant · cites it directly · 5 of its ownK171820 Transjugular Liver Access SetsCook Incorporated · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK202141 Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein…Argon Medical Devices, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK201489 Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga…Argon Medical Devices, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK221440 Liverty™ TIPS Access SetBard Peripheral Vascular, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK213638 Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga…Argon Medical Devices · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K142829 Flexor Tuohy-Borst Side-Arm Introducer, Ansel…direct predicate · 2015
Most influential descendants
Showing 5 of 6 · See all- K171820Transjugular Liver Access SetsCook Incorporated · 2018 · cites it directly5descendants
- K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc. · 2021 · 2 generations on1descendant
- K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein…Argon Medical Devices, Inc. · 2020 · 2 generations on1descendant
- K221440Liverty™ TIPS Access SetBard Peripheral Vascular, Inc. · 2022 · 2 generations on0descendants
- K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein…Argon Medical Devices · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −5 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −4 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −3 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −2 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| −1 | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo… | Cook Incorporated | 2015 | Class I |
| 0 (this device) | K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2016 | — |
| +1 | K171820 | Transjugular Liver Access Sets | Cook Incorporated | 2018 | 2 |
| +2 | K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | Argon Medical Devices, Inc. | 2021 | 1 |
| +2 | K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal… | Argon Medical Devices, Inc. | 2020 | — |
| +2 | K221440 | Liverty™ TIPS Access Set | Bard Peripheral Vascular, Inc. | 2022 | — |
| +3 | K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal… | Argon Medical Devices | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer…Summary page 4…cedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. Predicate Device Cook® Medical Flexor® Check-Flo II® Introducer Set, K142829 (component of the Haskal Transjugular Intrahepatic Portal Access Set) Cook® Medical Needle Catheter Combination Page 1 of… | 2015 |
| * | — | Cook Medical Needle Catheter Combination Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171820 | Transjugular Liver Access Sets | 2018 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2023 | Class II | Z-2249-2023 | Process control | Three lots of product may be labeled with an incorrect expiration day |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K142829Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification…Cook Incorporated · 2015 · Direct predicate · ◆ on the line of descent in FIG. 121 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171820 (Cook Incorporated, 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K142829.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The GORE TIPS Set, GORE TIPS Sheath and GORE TIPS Needle, are intended to be used together for percutaneous transjugular liver access during diagnostic and interventional procedures in patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152913: GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152913
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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