DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER— 510(k) K960176
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K960176 for DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER, Substantially Equivalent on 1996-07-24. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code FEG
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Canston, RI, US
Recent devices under product code FEG
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Adverse events under product code FEG
product code FEG- Death
- 2
- Total
- 2
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 K960176
K-number listed on FDA's recall record- Z-0790-2024 — Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
- Z-0791-2024 — Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
- Z-0792-2024 — Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
- Z-0793-2024 — Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
- Z-0794-2024 — Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
- Z-0795-2024 — Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
- Z-0796-2024 — Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100
- Z-0797-2024 — Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
- Z-0798-2024 — Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140
- Z-0799-2024 — Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160
- Z-0800-2024 — Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180
- Z-0801-2024 — Bard¿ Lopez Valve¿ with ENFit, REF EN0056000
- Z-0802-2024 — Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120
- Z-0803-2024 — Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140
- Z-0804-2024 — Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160
- Z-0805-2024 — Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180
- Z-0806-2024 — Bard¿ Suction Connector with ENFit, REF EN0066000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960176.
Data sourced from openFDA. This site is unofficial and independent of the FDA.