CORTRAK ENTERAL ACCESS DEVICE— 510(k) K113351
Substantially EquivalentCorpak Medsystems
FDA 510(k) clearance K113351 for CORTRAK ENTERAL ACCESS DEVICE, Substantially Equivalent on 2012-01-10. Applicant: Corpak Medsystems. Device class: 2.
Clearance details
- Applicant
- Corpak Medsystems
- 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
- Special
- Location
- Buffalo Grove, IL, US
Recent devices under product code KNT
view allMore clearances from Corpak Medsystems
view allAdverse 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 K113351
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 K113351.
Data sourced from openFDA. This site is unofficial and independent of the FDA.