# K152913: GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

- Pathway: 510(k) (Traditional)
- Applicant: Creganna Medical Aslo Business AS Cregganna Tactx Medical
- Decided: Jul 21, 2016 after 293 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924607 (1993). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142829: Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer, Cook Incorporated (2015) Summary page 4.
- (no number) Cook Medical Needle Catheter Combination: named in the summary without a submission number

## Most influential descendants
- K171820: Transjugular Liver Access Sets (2018), 5 descendants of its own
- K202141: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set (2021), 1 descendant of its own
- K201489: Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set (2020), 1 descendant of its own
- K221440: Liverty™ TIPS Access Set (2022), 0 descendants of its own
- K213638: Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) (2021), 0 descendants of its own

## Recalls of this device
- Jun 22, 2023 · Class II · Z-2249-2023: Three lots of product may be labeled with an incorrect expiration day

## Indications for use
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.

Source page: https://510kreport.com/device/K152913
Methodology: https://510kreport.com/methodology