FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K Number: K912972
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
52
Registration Numbers
53
Same Product Code
58
Applicant Total
857
Review Days
77
Basic Information
- Device Name
- FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
- K Number
- K912972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ABBOTT LABORATORIES
- Date Received
- July 8, 1991
- Decision Date
- September 23, 1991
- Product Code
- FPD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPD), ordered by most recent decision date.
Nutrifit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUTRISAFE 2 FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by ABBOTT LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Oct 23, 2017 | Substantially Equivalent |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | Aug 12, 2016 | Substantially Equivalent |
| K152442 | Freestyle Freedom Blood Glucose Monitoring Sytem | Dec 17, 2015 | Substantially Equivalent |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Jul 10, 2015 | Substantially Equivalent |
| K150332 | FreeStyle Lite Blood Glucose Monitoring System | Jun 5, 2015 | Substantially Equivalent |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | May 22, 2015 | Substantially Equivalent |
| K150510 | Total Bilirubin | Apr 2, 2015 | Substantially Equivalent |
| K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS | Feb 28, 2014 | Substantially Equivalent |
| K123089 | FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 | Apr 5, 2013 | Substantially Equivalent |