ARGYLE INDWELL FEEDING TUBE— 510(k) K820442
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K820442 for ARGYLE INDWELL FEEDING TUBE, Substantially Equivalent on 1982-03-10. Applicant: Sherwood Medical Co.. Device class: 2.
Clearance details
- Applicant
- Sherwood Medical Co.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KNT
view allMore clearances from Sherwood Medical Co.
view all- K981365 — MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS
- K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
- K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
- K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
- K960677 — KANGAROO JEJUNAL FEEDING SYSTEM
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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 K820442
K-number listed on FDA's recall record- Z-1033-2016 — Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.
- Z-1034-2016 — Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K820442.
Data sourced from openFDA. This site is unofficial and independent of the FDA.