AMT Mini™ Balloon Button 5-1225
by Applied Medical Technology, Inc.
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00842071110031 | Date2 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK945618 | Date12 Oct 1995 | StatusActive |
Official records
- AccessGUDID record 00842071110031
- FDA 510(k) database K945618
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AMT Mini™ Balloon Button
- Generic name
- Gastrostomy button
- Model / reference
- 5-1225
- Primary DI / UDI-DI
- 00842071110031
- 510(k) Number
- FDA product code
- KNT
- GMDN term
- Gastrostomy button
- Device class
- Class II
- Regulation number
- 876.5980
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 12 FrenchLength — 2.5 Centimeter
Other devices from Applied Medical Technology, Inc.
Properties
Other properties (8)
- Sterilise before use: No
- Contains latex: No
- Over-the-counter: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No