FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
K Number: K181423
·
Decision Sep 7, 2018
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
28
Review Days
99
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Basic Information
- Device Name
- AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
- K Number
- K181423
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amsino International, Inc.
- Date Received
- May 31, 2018
- Decision Date
- September 7, 2018
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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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 |
| 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 |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | Mar 30, 2018 | Substantially Equivalent |