FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NPseal
K Number: K212971
·
Decision Feb 10, 2022
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
16
Applicant Total
7
Review Days
146
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Basic Information
- Device Name
- NPseal
- K Number
- K212971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4683
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guard Medical, Inc.
- Date Received
- September 17, 2021
- Decision Date
- February 10, 2022
- Product Code
- OKO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OKO), ordered by most recent decision date.
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Other Clearances by Guard Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251156 | NPseal | May 15, 2025 | Substantially Equivalent |
| K250708 | NPseal | Apr 8, 2025 | Substantially Equivalent |
| K241522 | NPseal (20 and 25) | Aug 15, 2024 | Substantially Equivalent |
| K240244 | NPseal (Small, Medium, Large) | Feb 29, 2024 | Substantially Equivalent |
| K211130 | NPseal | May 14, 2021 | Substantially Equivalent |
| K200305 | NPseal | May 26, 2020 | Substantially Equivalent |