Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
FDA 510(k) clearance K193185 · decided 2020-05-04
Clearance details
- K-number
- K193185
- Device name
- Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
- Applicant
- Benq Materials Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-11-18
- Decision date
- 2020-05-04
- Days to decision
- 168 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
- Taoyuan, TW
- Third-party review
- No
- Expedited review
- No
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| NPseal (K200305) | Guard Medical, Inc. | 2020-05-26 |
| 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.