FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
IOGYN SYSTEM
K Number: DEN130040
·
Decision Mar 28, 2014
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
3
Review Days
210
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Basic Information
- Device Name
- IOGYN SYSTEM
- K Number
- DEN130040
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 884.1710
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- Iogyn, Inc.
- Date Received
- August 30, 2013
- Decision Date
- March 28, 2014
- Product Code
- PGT
- 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 |
|---|---|---|---|
| PGT | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar | FDA class 2 | Obstetrics/Gynecology |
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