FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medela Low Dose Enteral Syringe
K Number: K161811
·
Decision Feb 15, 2017
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
32
Applicant Total
19
Review Days
229
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Basic Information
- Device Name
- Medela Low Dose Enteral Syringe
- K Number
- K161811
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medela, Inc.
- Date Received
- July 1, 2016
- Decision Date
- February 15, 2017
- 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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FDA Class 2
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Nutricair Enteral Syringe with ENFit
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Oral/Enteral Syringe with ENFit connector
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ENFit enteral syringes (NUTRIFIT)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medela, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | Oct 28, 2016 | Substantially Equivalent |
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | Jun 6, 2003 | Substantially Equivalent |
| K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | Mar 7, 2002 | Substantially Equivalent |
| K984589 | PHOTOTHERAPY LAMP | Apr 20, 1999 | Substantially Equivalent |
| K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO | Jan 7, 1999 | Substantially Equivalent |
| K962612 | BILIBED PHOTOTHERAPY LAMP | Dec 12, 1996 | Substantially Equivalent |
| K950750 | MEDELAS BREAST PUMP | Oct 16, 1995 | Substantially Equivalent |
| K952034 | MEDELA'S FOOT PUMP | Sep 12, 1995 | Substantially Equivalent |
| K923577 | BREAST SHELLS | Jan 22, 1993 | Substantially Equivalent |
| K901344 | MEDELA BATTERY OPERATED BREAST PUMP | Aug 6, 1990 | Substantially Equivalent |