FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NeoMed NeoConnect Enteral Syringes with ENFit Connector
K Number: K143344
·
Decision Apr 9, 2015
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
32
Applicant Total
13
Review Days
139
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Basic Information
- Device Name
- NeoMed NeoConnect Enteral Syringes with ENFit Connector
- K Number
- K143344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neomed, Inc.
- Date Received
- November 21, 2014
- Decision Date
- April 9, 2015
- 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
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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)
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Nutricair Enteral Syringe with ENFit
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ENFit enteral syringes (NUTRIFIT)
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Other Clearances by Neomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | Apr 30, 2019 | Substantially Equivalent |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | Jun 17, 2016 | Substantially Equivalent |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | Dec 17, 2015 | Substantially Equivalent |
| K122373 | NEOMED ORAL/ENTERAL SYRINGE | Sep 20, 2012 | Substantially Equivalent |
| K120182 | NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES | Apr 19, 2012 | Substantially Equivalent |
| K100288 | NEOMED ENTERAL ONLY EXTENSION SET | Aug 3, 2010 | Substantially Equivalent |
| K092908 | NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO | Mar 10, 2010 | Substantially Equivalent |
| K082238 | NEOMED POLYURETHANE FEEDING TUBE | Oct 1, 2008 | Substantially Equivalent |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | Jul 21, 2008 | Substantially Equivalent |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | Feb 22, 2008 | Substantially Equivalent |