Chrysalis Intelligence · Product Codes · PIF

PIF · Gastrointestinal Tubes With Enteral Specific Connectors

Gastroenterology, Urology · 23 clearances · 19 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Device class

Class II

Regulation 876.5980

Total clearances

2020-07-30 → 2026-09-10

Last 12 months

Unique sponsors

Definition

What is Gastrointestinal Tubes With Enteral Specific Connectors

To facilitate enteral specific connections.

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.5980

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Cair Lgl	2	0	2022-06-09
Vesco Medical, LLC	2	0	2023-11-02
Rockfield Medical	2	0	2024-04-12
Vonco Products	2	0	2023-07-10
Danumed Medizintechnik GmbH	1	1	2026-09-10
Three Circles Consulting Limited	1	0	2020-10-01
GBUK Group, Ltd.	1	0	2021-08-19
Beijing L&Z Medical Technology Development Co., Ltd.	1	0	2024-07-03
HMC Premedical S.p.A.	1	0	2025-06-18
Kb Medical (Group), Inc.	1	0	2021-11-16
Mps Medical, Inc.	1	0	2020-07-30
Syncro Medical Innovations, Inc.	1	0	2020-11-05
Wilson-Cook Medical, Inc.	1	0	2022-01-20
Anhui Tiankang Medical Technology Co., Ltd.	1	0	2023-08-17
Maquet Critical Care AB	1	1	2026-08-26
SKY Medical, a.s.	1	0	2025-04-18
Cardinalhealth	1	0	2022-05-19
Xeridiem Medical Devices, A Spectrum Plastics Group Company	1	0	2023-10-06
Degania Silicone , Ltd.	1	1	2026-03-20

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
43752	CPT	—	Medium	Nasogastric feeding tube placement; CPT for enteral tube with connector placement
B4083	HCPCS	Stomach tube - levine type ✓ CMS-verified description	Medium	HCPCS for enteral feeding supply/tube connector devices

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-10	K260110	Danumed Medizintechnik GmbH	danumed Extension Set for Gastrostomy Button
2026-08-26	K253715	Maquet Critical Care AB	Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)
2026-03-20	K254170	Degania Silicone , Ltd.	Percutaneous Endoscopic Gastrostomy (PEG) Kit
2025-06-18	K242917	HMC Premedical S.p.A.	Enteral Drainage System, Enteral Medicine straw
2025-04-18	K250481	SKY Medical, a.s.	Extension Feeding Set with ENFit Connectors
2024-07-03	K240052	Beijing L&Z Medical Technology Development Co., Ltd.	Disposable Enteral Feeding Sets
2024-04-12	K233034	Rockfield Medical	Mobility+ Enteral Feeding System OTC
2023-11-02	K230326	Vesco Medical	ENFit to ENFit Extension Sets
2023-10-06	K232046	Xeridiem Medical Devices, A Spectrum Plastics Group Company	Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
2023-08-17	K222773	Anhui Tiankang Medical Technology Co., Ltd.	Feeding Tube
2023-07-10	K223683	Vonco Products	EnteraLoc Flow
2022-10-27	K222678	Rockfield Medical	Mobility+ Enteral Feeding System
2022-06-09	K213258	Cair Lgl	Nasogastric Feeding Tubes - ENFit Port - PVC
2022-05-19	K213174	Cardinalhealth	Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
2022-01-20	K213356	Wilson-Cook Medical, Inc.	Entuit PEG, Entuit PEGJ
2021-11-16	K210854	Kb Medical (Group), Inc.	Enteral Feeding Set
2021-11-02	K210598	Cair Lgl	Pediatric Nasogastric Feeding Tubes - Single ENFit Port
2021-08-19	K203633	GBUK Group, Ltd.	Enteral Extension Sets
2021-08-18	K210971	Vonco Products	EnteraLoc Flow
2020-11-05	K201741	Syncro Medical Innovations, Inc.	Gabriel 3 Way EnFit Valve
2020-10-01	K202357	Three Circles Consulting Limited	Nutricare Clear-ISOSAF Nasogastric Feeding Tube
2020-08-03	K192991	Vesco Medical, LLC	Vesco Medical Extension Feeding Set
2020-07-30	K200082	Mps Medical, Inc.	BD Univia RightFit Enteral Extension Sets and Transitional Adapters