Atlas FDA

EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

FDA 510(k) clearance K161003 · decided 2016-06-17

Clearance details

K-number
K161003
Device name
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
Applicant
Boston Scientific Corporation
Decision
Unknown
Date received
2016-04-11
Decision date
2016-06-17
Days to decision
67 days
Clearance type
Traditional
Product code
PIF
Device class
2
Regulation number
876.5980
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Percutaneous Endoscopic Gastrostomy (PEG) Kit (K254170)Degania Silicone , Ltd.2026-03-20
Enteral Drainage System, Enteral Medicine straw (K242917)HMC Premedical S.p.A.2025-06-18
Extension Feeding Set with ENFit™ Connectors (K250481)SKY Medical, a.s.2025-04-18
Disposable Enteral Feeding Sets (K240052)Beijing L&Z Medical Technology Development Co., Ltd.2024-07-03
Mobility+ Enteral Feeding System OTC (K233034)Rockfield Medical2024-04-12
ENFit to ENFit Extension Sets (K230326)Vesco Medical2023-11-02
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection (K232046)Xeridiem Medical Devices, A Spectrum Plastics Group Company2023-10-06
Feeding Tube (K222773)Anhui Tiankang Medical Technology Co., Ltd.2023-08-17
EnteraLoc Flow (K223683)Vonco Products2023-07-10
Mobility+ Enteral Feeding System (K222678)Rockfield Medical2022-10-27
Nasogastric Feeding Tubes - ENFit Port - PVC (K213258)Cair Lgl2022-06-09
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (K213174)Cardinalhealth2022-05-19

Recalls involving this device

RecordFirmDate
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. recall (Z-1153-2024)Boston Scientific Corporation2024-02-16

PMA approvals by this applicant

RecordFirmDate
Axonics Sacral Neuromodulation System (P190006/S101)Boston Scientific Corporation2025-12-19
Axonics Sacral Neuromodulation System (P180046/S101)Boston Scientific Corporation2025-12-19
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110)Boston Scientific Corporation2025-10-29
Innova™ Vascular Self-Expanding Stent System (P140028/S084)Boston Scientific Corporation2025-10-24
Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019/S039)Boston Scientific Corporation2025-10-24
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S007)Boston Scientific Corporation2025-10-24
ENROUTE® Transcarotid Stent System (P140026/S032)Boston Scientific Corporation2025-10-23
A209 SICD Gen 2,A219 SICD MRI (P110042/S206)Boston Scientific Corporation2025-10-22