2D Mercy TAPE & 3D Mercy TAPE
FDA 510(k) clearance K142469 · decided 2015-05-01
Clearance details
- K-number
- K142469
- Device name
- 2D Mercy TAPE & 3D Mercy TAPE
- Applicant
- Children'S Mercy Hospital
- Decision
- Substantially Equivalent
- Date received
- 2014-09-03
- Decision date
- 2015-05-01
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- PIR
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kansas City, MO, 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 |
|---|---|---|
| Mercy babyTAPE (K191174) | Children'S Mercy Hospital | 2019-10-10 |
Recalls involving this device
No recalls on record reference this clearance.