AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
FDA 510(k) clearance K073034 · decided 2008-03-14
Clearance details
- K-number
- K073034
- Device name
- AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
- Applicant
- Applied Medical Technology, Inc.
- Decision
- Unknown
- Date received
- 2007-10-26
- Decision date
- 2008-03-14
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AMT Initial Placement Dilator Set. Used to place gastrostomy devices. recall (Z-2238-2024) | Applied Medical Technology Inc | 2024-06-28 |