npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
FDA 510(k) clearance K201400 · decided 2021-08-23
Clearance details
- K-number
- K201400
- Device name
- npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
- Applicant
- Aatru Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-05-28
- Decision date
- 2021-08-23
- Days to decision
- 452 days
- Clearance type
- Traditional
- Product code
- QPX
- Device class
- 2
- Regulation number
- 878.4683
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Aatru Medical
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.
Recalls involving this device
No recalls on record reference this clearance.