FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Stasis Gel
K Number: K211420
·
Decision Mar 14, 2022
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
35
Applicant Total
11
Review Days
311
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Basic Information
- Device Name
- Stasis Gel
- K Number
- K211420
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Belport Company, Inc., Gingi-Pak
- Date Received
- May 7, 2021
- Decision Date
- March 14, 2022
- Product Code
- MVL
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| MVL | Cord, Retraction | FDA unclassified | Unknown |
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