Chrysalis Intelligence · Product Codes · PIF

PIF · Gastrointestinal Tubes With Enteral Specific Connectors

Gastroenterology, Urology · 21 clearances · 17 unique sponsors

Device class
Class II
Regulation 876.5980
Total clearances
21
2020-07-30 → 2026-03-20
Last 12 months
1
Unique sponsors
17
Definition

What is Gastrointestinal Tubes With Enteral Specific Connectors

To facilitate enteral specific connections.
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5980
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

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

CodeTypeDescriptionConfidenceRationale
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

DateK-numberSponsorDevice
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