Corflo Cubby Low Profile Gastrostomy Device (LPGD)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990127 FDA 510(k)
- FDA Product Code
- KNT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Corflo Cubby Low Profile Gastrostomy Device (LPGD) is a low-profile gastrostomy device designed for enteral feeding and gastric decompression. It delivers nutritional solutions directly into the stomach and supports decompression via a dedicated tube, providing stable access for patients with intact alimentary tracts who cannot tolerate oral intake.
This device is used in clinical settings by healthcare professionals. It is supplied as a kit with ENFit Connectors and is identified by model number 35-1645 and K-number K990127. The device received FDA 510(k) clearance on February 10, 1999, under product code KNT, and is manufactured by Corpak Medsystems in Wheeling, Illinois.
Frequently asked questions
What is the Corflo Cubby Low Profile Gastrostomy Device used for?
The Corflo Cubby Low Profile Gastrostomy Device (LPGD) is designed for enteral feeding and gastric decompression, delivering nutritional solutions directly into the stomach and supporting decompression via a dedicated tube for patients with intact alimentary tracts who cannot tolerate oral intake.
How is the Corflo Cubby LPGD supplied and what model number does it have?
The device is supplied as a kit with ENFit Connectors and is identified by model number 35-1645, as specified in the device data for the Corflo Cubby Low Profile Gastrostomy Device (LPGD).
Is the Corflo Cubby LPGD intended for single-use or reuse?
The device data does not specify whether the Corflo Cubby LPGD is intended for single-use or reuse; therefore, no determination can be made about its reusability based solely on the provided information.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Corflo Cubby Low Profile Gastrostomy Device (Lpgd), AccessGUDID - DEVICE: CORFLO cuBBy LPGD (10815149022809), AccessGUDID - DEVICE: CORFLO cuBBy LPGD (10815149024940), CORFLO cuBBy LPGD - BEUDAMED, CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD) 510 (k) K990127 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990127 | Class II | Active |
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Manufacturer
- Manufacturer
- Corpak Medsystems
Sources (1)
- FDA 510(k) K990127 24 fields · synced Sep 24, 2026