Aspire Mechanical Aspirator G

FDA 510(k) K200629 · Control Medical Technology

Substantially Equivalent

510(k) numberK200629

Submission

Device name
Aspire Mechanical Aspirator G
Applicant
Control Medical Technology
Salt Lake City, UT, US
Received
March 10, 2020
Decision date
May 29, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FMF – Syringe, Piston
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

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Questions and answers

When was Aspire Mechanical Aspirator G cleared by the FDA?

Aspire Mechanical Aspirator G (K200629) received a 510(k) decision of Substantially Equivalent on May 29, 2020, 80 days after the submission was received.

What is the product code of K200629?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.