# K233318: AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) - Pathway: 510(k) (Special) - Applicant: Boston Scientific Corporation - Decided: Oct 27, 2023 after 28 days - Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)) - Device class: 2 - Regulation: 21 CFR 876.4300 - Recalls of this device: 18 (6 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to DEN230019 (2023). 1 ancestor in all. 1 later device descends from it; 1 cites it directly. 1 of 3 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - DEN230019: AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent), Boston Scientific Corporation (2023) Summary page 5. ## Cited in the summary but kept off the family tree - K220191: Disposable Face Mask, Jiujiang Taixin Technology Co., Ltd. (2022). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree ## Most influential descendants - K252648: Niti-S SPAXUS Stent (2026), 0 descendants of its own ## Recalls of this device - Dec 19, 2025 · Class I · Z-1162-2026: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange th - Dec 19, 2025 · Class I · Z-1160-2026: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange th - Dec 19, 2025 · Class I · Z-1163-2026: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange th - Dec 19, 2025 · Class I · Z-1158-2026: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange th - Dec 19, 2025 · Class I · Z-1159-2026: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange th - Dec 19, 2025 · Class I · Z-1161-2026: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange th - Dec 20, 2024 · Class II · Z-1025-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1026-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1027-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1029-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1032-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1033-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1037-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1024-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1028-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1034-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1035-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for - Dec 20, 2024 · Class II · Z-1036-2025: Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for ## Indications for use 6mmx8mm and 8mmx8mm stents: The AXIOS Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution. 1Ommx10mm and 15mmx10mm stents: The AXIOS Electrocautery-Enhanced-Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts 6 cm in size and walled-off necrosis ! 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the AXIOS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. The AXIOS Stent and Electrocautery-Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery. 20mmx10mm and 15mmx15mm stents: The AXIOS Electrocautery-Enhanced Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts 2 6 cm in size and walled-off necrosis 6 cm in size that are adherent to the gastric or bowel wall. Once placed, the AXIOS Stent functions as an access port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. Source page: https://510kreport.com/device/K233318 Methodology: https://510kreport.com/methodology