CISNAP CLOSED INCISION SYSTEM
FDA 510(k) clearance K133137 · decided 2014-02-25
Clearance details
- K-number
- K133137
- Device name
- CISNAP CLOSED INCISION SYSTEM
- Applicant
- Spiracur, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-11
- Decision date
- 2014-02-25
- Days to decision
- 137 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
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| SNAP WOUND CARE SYSTEM (K113032) | Spiracur, Inc. | 2011-12-01 |
Recalls involving this device
No recalls on record reference this clearance.