Identifiers
- 510(k) Number
- K860818 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 ONE TIME ENTERAL FEEDING BAG (product code: KNT, decision_code: SESE) is a medical device designed for the administration of nutrition to individuals with gastrointestinal disorders. This device features a patented tube structure that allows for secure and efficient feeding, while also providing a comfortable and hygienic experience for users.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860818 | Class II | Active |
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Manufacturer
- Manufacturer
- Acme United Corp.
Sources (1)
- FDA 510(k) K860818 24 fields · synced Jul 22, 2026