Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
FDA 510(k) clearance K162721 · decided 2016-12-22
Clearance details
- K-number
- K162721
- Device name
- Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator
- Applicant
- Alliqua Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-29
- Decision date
- 2016-12-22
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- NRB
- Device class
- 2
- Regulation number
- 878.4410
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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| MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES (K112782) | Misonix, Inc. | 2011-12-01 |
| AS 1000 ULTRASOUND WOUND THERAPY SYSTEM (K091038) | Arobella Medical, LLC | 2009-06-19 |
| CELLERATION MIST THERAPY SYSTEM 5.1 (K050129) | Celleration, Inc. | 2005-05-17 |
| CELLERATION MIST THERAPY SYSTEM (DEN040004) | Celleration | 2004-06-25 |
Recalls involving this device
No recalls on record reference this clearance.