AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
FDA 510(k) clearance K100526 · decided 2010-04-22
Clearance details
- K-number
- K100526
- Device name
- AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
- Applicant
- Kentec Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-24
- Decision date
- 2010-04-22
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c recall (Z-3073-2017) | Kentec Medical Inc | 2017-07-22 |
| POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-4 recall (Z-3074-2017) | Kentec Medical Inc | 2017-07-22 |