FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AccuSert Needle Inserter
K Number: K213429
·
Decision Oct 20, 2022
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
46
Applicant Total
11
Review Days
364
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Basic Information
- Device Name
- AccuSert Needle Inserter
- K Number
- K213429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6920
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emed Technologies Corporation
- Date Received
- October 21, 2021
- Decision Date
- October 20, 2022
- Product Code
- KZH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KZH | Introducer, Syringe Needle | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K173783 | SCIg60 Infusion System | Dec 14, 2018 | Substantially Equivalent |
| K161906 | SCIg60 Infuser | Dec 1, 2016 | Substantially Equivalent |
| K142319 | SCIg60 Infuser, Infuset | May 14, 2015 | Substantially Equivalent |
| K140133 | INFUSET FLOW CONTROL EXTENSION SET | May 15, 2014 | Substantially Equivalent |
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| K123729 | VERSARATE FLOW RATE CONTROLER | Dec 21, 2012 | Substantially Equivalent |