FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iVitri Straw
K Number: K172751
·
Decision Feb 9, 2018
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
2
Review Days
150
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Basic Information
- Device Name
- iVitri Straw
- K Number
- K172751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reprobitech Corp.
- Date Received
- September 12, 2017
- Decision Date
- February 9, 2018
- Product Code
- MQK
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| MQK | Labware, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Reprobitech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K162640 | iVitri EZ | Jun 30, 2017 | Substantially Equivalent |