510(k) K810156 ยท KNT Tubes, Gastrointestinal (And Accessories)
ARGYLE SALEM SUMP TUBE
| Applicant | Sherwood Medical Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 2, 1981 |
| Received | Jan 21, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2025 | Cardinal Health 200, LLC Salem Sump PVC Tubes:
Product Code/Product Name:
264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm)
264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm)
264960 Salem Sump" Stoma Open, Classified |
KNT | None listed |
| Sep 26, 2024 | Cardinal Health 200, LLC (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile;
(b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 Open, Classified |
KNT | None listed |
| Oct 31, 2018 | COVIDIEN LLC Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911
Product Usage:
The Salem Sump Tubes are intended for decompression and drainage of stomach contents followi Terminated |
KNT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.