Amt Button Replacement Gastrostomy Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980305 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 Amt Button Replacement Gastrostomy Device is an injection-molded silicone tube designed for use in patients with an established stoma. It functions as a feeding device to provide nutrition, medication, or gastric decompression.
This device features a dome and an anti-reflux valve, both of which contain barium for radiopacity. It is authorized under FDA 510(k) clearance K980305.
Frequently asked questions
What is the primary function of the AMT Button Replacement Gastrostomy Device?
This device is designed for patients with an established stoma. It serves as a feeding tube to provide necessary nutrition and medication, and it can also be used for gastric decompression.
What materials are used in the construction of this device?
The device is manufactured as an injection-molded silicone tube. To assist with clinical visualization, the dome and the anti-reflux valve are formulated with barium to ensure they are radiopaque.
What is the regulatory status of this gastrostomy device?
The AMT Button Replacement Gastrostomy Device is authorized under FDA 510(k) clearance K980305, which was granted on April 16, 1998, following a determination of substantial equivalence.
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: AMT Button G Tube, Low Profile Original - AMT, AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE (K980305) — FDA 510(k ..., 510 (k) Premarket Notification - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980305 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
Sources (1)
- FDA 510(k) K980305 24 fields · synced Sep 21, 2026