FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORAL/ENTERAL SYRINGES
K Number: K100099
·
Decision Jun 14, 2010
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
1
Review Days
152
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ORAL/ENTERAL SYRINGES
- K Number
- K100099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Children'S Medical Ventures
- Date Received
- January 13, 2010
- Decision Date
- June 14, 2010
- Product Code
- FPD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- Y
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