AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
FDA 510(k) K181423 · Amsino International, Inc.
510(k) numberK181423
Submission
- Device name
- AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
- Applicant
- Amsino International, Inc.
Pomona, CA, US - Received
- May 31, 2018
- Decision date
- September 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| 510(k) | Device | Decision |
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| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | 05/04/2026SE |
| K220230 | AMSure Enteral Feeding PumpLZH · Traditional | 11/10/2022SE |
| K220267 | AMSafe NeuFlo Needleless ConnectorFPA · Traditional | 10/07/2022SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 03/22/2022SE |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding SetLZH · Traditional | 09/25/2020SE |
| K183473 | AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 07/12/2019SE |
| K181445 | AMSure Hydrophilic Intermittent CatheterEZD · Traditional | 10/01/2018SE |
| K173665 | AMSafe Sure-Lok Needle-Free ConnectorFPA · Traditional | 09/05/2018SE |
| K181814 | AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterEZL · Traditional | 09/04/2018SE |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit TipPNR · Traditional | 03/30/2018SE |
Questions and answers
When was AMSure Sterile Water, and Sterile Normal Saline for Wound Flush cleared by the FDA?
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush (K181423) received a 510(k) decision of Substantially Equivalent on September 7, 2018, 99 days after the submission was received.
What is the product code of K181423?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.