FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Invictus Medical GelShield
K Number: K150243
·
Decision May 1, 2015
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- Invictus Medical GelShield
- K Number
- K150243
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Invictus Medical, Inc.
- Date Received
- February 2, 2015
- Decision Date
- May 1, 2015
- Product Code
- FMP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Invictus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN220048 | Neoasis | Jun 16, 2023 | Unknown |