FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Epi-Stop Nasal Gel/epistaxis pack
K Number: K230142
·
Decision Mar 22, 2023
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
45
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- Epi-Stop Nasal Gel/epistaxis pack
- K Number
- K230142
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4780
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomed Ent, Inc.
- Date Received
- January 18, 2023
- Decision Date
- March 22, 2023
- Product Code
- LYA
- 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 |
|---|---|---|---|
| LYA | Splint, Intranasal Septal | FDA class 1 | Ear, Nose, Throat |
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