SNAP WOUND CARE DEVICE
FDA 510(k) clearance DEN080011 · decided 2009-08-07
Clearance details
- K-number
- DEN080011
- Device name
- SNAP WOUND CARE DEVICE
- Applicant
- Spiracur, Inc.
- Decision
- Unknown
- Date received
- 2008-11-03
- Decision date
- 2009-08-07
- Days to decision
- 277 days
- Clearance type
- Post-NSE
- Product code
- OKO
- Device class
- 2
- Regulation number
- 878.4683
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Philadelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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| NPseal (K211130) | Guard Medical, Inc. | 2021-05-14 |
| NPseal (K200305) | Guard Medical, Inc. | 2020-05-26 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.