AeroForm Tissue Expander, Smooth
FDA 510(k) clearance K191138 · decided 2019-07-11
Clearance details
- K-number
- K191138
- Device name
- AeroForm Tissue Expander, Smooth
- Applicant
- Airxpanders, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-30
- Decision date
- 2019-07-11
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- PQN
- Device class
- 2
- Regulation number
- 878.3510
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, 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 |
|---|---|---|
| AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) (K170075) | Airxpanders, Inc. | 2017-04-03 |
| AeroForm Tissue Expander System (DEN150055) | Airxpanders, Inc. | 2016-12-21 |
Recalls involving this device
No recalls on record reference this clearance.