FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
K Number: K200557
·
Decision Sep 28, 2020
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
32
Applicant Total
3
Review Days
209
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
- Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
- K Number
- K200557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jiangsu Shenli Medical Production Co., Ltd.
- Date Received
- March 3, 2020
- Decision Date
- September 28, 2020
- Product Code
- PNR
- 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 |
|---|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNR), ordered by most recent decision date.
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Profoject Enteral Feeding Syringe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Nutricair Enteral Syringe with ENFit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oral/Enteral Syringe with ENFit connector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENFit enteral syringes (NUTRIFIT)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology