Quiver Aspiration Pump

FDA 510(k) K232831 · Anoxia Medical, Inc.

Substantially Equivalent

510(k) numberK232831

Submission

Device name
Quiver Aspiration Pump
Applicant
Anoxia Medical, Inc.
Hayward, CA, US
Received
September 13, 2023
Decision date
February 22, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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Questions and answers

When was Quiver Aspiration Pump cleared by the FDA?

Quiver Aspiration Pump (K232831) received a 510(k) decision of Substantially Equivalent on February 22, 2024, 162 days after the submission was received.

What is the product code of K232831?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.