FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-FLO Fluid Management System
K Number: K210628
·
Decision Nov 4, 2021
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
55
Applicant Total
5
Review Days
247
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Basic Information
- Device Name
- X-FLO Fluid Management System
- K Number
- K210628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermedx, LLC
- Date Received
- March 2, 2021
- Decision Date
- November 4, 2021
- Product Code
- HIG
- 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 |
|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Thermedx, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K172048 | FluidSmart | Sep 5, 2017 | Substantially Equivalent |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Jun 20, 2014 | Substantially Equivalent |
| K102275 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 | Mar 25, 2011 | Substantially Equivalent |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | Jul 23, 2010 | Substantially Equivalent |