FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Gas Insufflator
K Number: K221995
·
Decision Mar 28, 2023
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
174
Applicant Total
7
Review Days
265
Basic Information
- Device Name
- Gas Insufflator
- K Number
- K221995
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Date Received
- July 6, 2022
- Decision Date
- March 28, 2023
- Product Code
- HIF
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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