Mercy babyTAPE
FDA 510(k) clearance K191174 · decided 2019-10-10
Clearance details
- K-number
- K191174
- Device name
- Mercy babyTAPE
- Applicant
- Children'S Mercy Hospital
- Decision
- Substantially Equivalent
- Date received
- 2019-05-01
- Decision date
- 2019-10-10
- Days to decision
- 162 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
+ Add to Predicate Builder ◉ Watch Children'S Mercy Hospital
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 2D Mercy TAPE & 3D Mercy TAPE (K142469) | Children'S Mercy Hospital | 2015-05-01 |
Recalls involving this device
No recalls on record reference this clearance.