FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aqueduct 100 Plus Cervical Dilation Balloon Catheter
K Number: K202427
·
Decision Nov 6, 2020
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
3
Review Days
73
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Basic Information
- Device Name
- Aqueduct 100 Plus Cervical Dilation Balloon Catheter
- K Number
- K202427
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.4260
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gtimd, LLC
- Date Received
- August 25, 2020
- Decision Date
- November 6, 2020
- Product Code
- PON
- 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 |
|---|---|---|---|
| PON | Catheter, Balloon, Dilation Of Cervical Canal | FDA class 2 | Obstetrics/Gynecology |
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