Aprima Smartesis Centesis Pump
FDA 510(k) K161002 · Cook Incorporated
510(k) numberK161002
Submission
- Device name
- Aprima Smartesis Centesis Pump
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- April 11, 2016
- Decision date
- September 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
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Questions and answers
When was Aprima Smartesis Centesis Pump cleared by the FDA?
Aprima Smartesis Centesis Pump (K161002) received a 510(k) decision of Substantially Equivalent on September 28, 2016, 170 days after the submission was received.
What is the product code of K161002?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.