510(k) K100526 ยท FPD Tube, Feeding
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
| Applicant | Kentec Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 22, 2010 |
| Received | Feb 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | None listed |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | None listed |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | None listed |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube). Terminated |
FPD | None listed |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port). Terminated |
FPD | None listed |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port). Terminated |
FPD | None listed |
| Jan 17, 2020 | Kentec Medical, Inc Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port). Terminated |
FPD | None listed |
| Jul 22, 2017 | Kentec Medical Inc POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers:
a) ENF-50P-40
b) ENF-50P-50
c) ENF-50P-80
d) ENF-60P-40
e) ENF-60P-50
f) ENF-60P-80
g) ENF-80P-40
h) ENF-80P-50
i) ENF-80P-80
j Terminated |
FPD | None listed |
| Jul 22, 2017 | Kentec Medical Inc POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers:
a) ENF-Y50P-40
b) ENF-Y50P-50
c) ENF-Y60P-40
d) ENF-Y60P-50
e) ENF-Y60P-90
f) ENF-Y80P-40
g) ENF-Y80P-50
h) ENF-Y Terminated |
FPD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.