Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit— 510(k) K180708
UnknownXeridiem Medical Devices, A Spectrum Plastics Group Company
FDA 510(k) clearance K180708 for Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit, Unknown on 2018-10-18. Applicant: Xeridiem Medical Devices, A Spectrum Plastics Group Company. Device class: 2.
Clearance details
- Applicant
- Xeridiem Medical Devices, A Spectrum Plastics Group Company
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
Recent devices under product code PIF
view allMore clearances from Xeridiem Medical Devices, A Spectrum Plastics Group Company
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.