FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRIS Thermocoagulator and Digital Colposcope
K Number: K202915
·
Decision Apr 23, 2021
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
52
Applicant Total
3
Review Days
206
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Basic Information
- Device Name
- IRIS Thermocoagulator and Digital Colposcope
- K Number
- K202915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Liger Medical, LLC
- Date Received
- September 29, 2020
- Decision Date
- April 23, 2021
- Product Code
- HGI
- 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 |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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