Aprima Smartesis Centesis Pump
510(k) K161002
Aprima Smartesis Centesis Pump is a medical device (FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by Cook Incorporated, cleared under FDA 510(k) K161002 on 28 Sep 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161002 | Date28 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K161002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BTA
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4780
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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