ARGYLE SALEM SUMP TUBE
FDA 510(k) clearance K810156 · decided 1981-03-02
Clearance details
- K-number
- K810156
- Device name
- ARGYLE SALEM SUMP TUBE
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-01-21
- Decision date
- 1981-03-02
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- KNT
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lum recall (Z-0207-2026) | Cardinal Health 200, LLC | 2025-10-17 |
| (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm) recall (Z-3301-2024) | Cardinal Health 200, LLC | 2024-09-26 |