FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMSure® Enteral Feeding Syringe with ENFit Tip
K Number: K171857
·
Decision Mar 30, 2018
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
32
Applicant Total
28
Review Days
282
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Basic Information
- Device Name
- AMSure® Enteral Feeding Syringe with ENFit Tip
- K Number
- K171857
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amsino International, Inc.
- Date Received
- June 21, 2017
- Decision Date
- March 30, 2018
- 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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FDA Class 2
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Other Clearances by Amsino International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | May 4, 2026 | Substantially Equivalent |
| K220230 | AMSure Enteral Feeding Pump | Nov 10, 2022 | Substantially Equivalent |
| K220267 | AMSafe NeuFlo Needleless Connector | Oct 7, 2022 | Substantially Equivalent |
| K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe | Mar 22, 2022 | Substantially Equivalent |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding Set | Sep 25, 2020 | Substantially Equivalent |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe | Jul 12, 2019 | Substantially Equivalent |
| K181445 | AMSure Hydrophilic Intermittent Catheter | Oct 1, 2018 | Substantially Equivalent |
| K181423 | AMSure Sterile Water, and Sterile Normal Saline for Wound Flush | Sep 7, 2018 | Substantially Equivalent |
| K173665 | AMSafe Sure-Lok Needle-Free Connector | Sep 5, 2018 | Substantially Equivalent |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water | Sep 4, 2018 | Substantially Equivalent |