NPseal
FDA 510(k) clearance K200305 · decided 2020-05-26
Clearance details
- K-number
- K200305
- Device name
- NPseal
- Applicant
- Guard Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-06
- Decision date
- 2020-05-26
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- OKO
- Device class
- 2
- Regulation number
- 878.4683
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NPseal (K251156) | Guard Medical, Inc. | 2025-05-15 |
| NPseal (K250708) | Guard Medical, Inc. | 2025-04-08 |
| NPseal (20 and 25) (K241522) | Guard Medical, Inc. | 2024-08-15 |
| NPseal (Small, Medium, Large) (K240244) | Guard Medical, Inc. | 2024-02-29 |
| NPseal (K212971) | Guard Medical, Inc. | 2022-02-10 |
| NPseal (K211130) | Guard Medical, Inc. | 2021-05-14 |
| Anscare SIMO Negative Pressure Wound Therapy (NPWT) System (K193185) | Benq Materials Corporation | 2020-05-04 |
| SNaP Wound Care System (K151710) | Spiracur, Inc. | 2015-11-19 |
| SNaP Wound Care System (K142272) | Spiracur, Inc. | 2014-11-25 |
| SNAP WOUND CARE SYSTEM (K132080) | Spiracur, Inc. | 2014-03-12 |
| CISNAP CLOSED INCISION SYSTEM (K133137) | Spiracur, Inc. | 2014-02-25 |
| SNAP WOUND CARE SYSTEM (K113032) | Spiracur, Inc. | 2011-12-01 |
Recalls involving this device
No recalls on record reference this clearance.