Salem Sump Dual Lumen Stomach Tube with ENFit Connection— 510(k) K190923
Substantially EquivalentCardinalhealth
FDA 510(k) clearance K190923 for Salem Sump Dual Lumen Stomach Tube with ENFit Connection, Substantially Equivalent on 2019-11-07. Applicant: Cardinalhealth. Device class: 2.
Clearance details
- Applicant
- Cardinalhealth
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code PIF
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- K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)
- K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) +1 more
Adverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K190923
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190923.
Data sourced from openFDA. This site is unofficial and independent of the FDA.