FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Rhinolaryngoscope system
K Number: K232435
·
Decision Apr 26, 2024
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
8
Review Days
256
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Basic Information
- Device Name
- Rhinolaryngoscope system
- K Number
- K232435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Date Received
- August 14, 2023
- Decision Date
- April 26, 2024
- Product Code
- EOB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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|---|---|---|---|
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| K240374 | Ureterorenoscope System | May 10, 2024 | Substantially Equivalent |
| K231497 | Choledochoscope System | Mar 6, 2024 | Substantially Equivalent |
| K231118 | Cystoscope System | Nov 13, 2023 | Substantially Equivalent |
| K222910 | Bronchoscope System | Apr 11, 2023 | Substantially Equivalent |