Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
FDA 510(k) clearance K232046 · decided 2023-10-06
Clearance details
- K-number
- K232046
- Device name
- Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
- Applicant
- Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Decision
- Substantially Equivalent
- Date received
- 2023-07-10
- Decision date
- 2023-10-06
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PIF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 Medical | 2024-04-12 |
| ENFit to ENFit Extension Sets (K230326) | Vesco Medical | 2023-11-02 |
| Feeding Tube (K222773) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| EnteraLoc Flow (K223683) | Vonco Products | 2023-07-10 |
| Mobility+ Enteral Feeding System (K222678) | Rockfield Medical | 2022-10-27 |
| Nasogastric Feeding Tubes - ENFit Port - PVC (K213258) | Cair Lgl | 2022-06-09 |
| Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (K213174) | Cardinalhealth | 2022-05-19 |
| Entuit PEG, Entuit PEGJ (K213356) | Wilson-Cook Medical, Inc. | 2022-01-20 |
Recalls involving this device
No recalls on record reference this clearance.