MICROAIRE SURGICAL INSTRUMENTS LLC— 510(k) K113128

Name: FDA 510(k) clearance K113128
Creator: U.S. Food and Drug Administration
Published: 2012-08-17

Substantially Equivalent

Microaire Surgical Instruments, LLC

FDA 510(k) clearance K113128 for MICROAIRE SURGICAL INSTRUMENTS LLC, Substantially Equivalent on 2012-08-17. Applicant: Microaire Surgical Instruments, LLC. Device class: 2.

Clearance details

Applicant: Microaire Surgical Instruments, LLC
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2011-10-24
Decision date: 2012-08-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chesterfield, VA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K113128

K-number listed on FDA's recall record

Z-2821-2015 — ASP-1020 LipoTower with Aspiration Pump. Medical use.Class II·Terminated·MicroAire Surgical Instruments, LLC·20150612
Z-2822-2015 — ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.Class II·Terminated·MicroAire Surgical Instruments, LLC·20150612

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113128.

Data sourced from openFDA. This site is unofficial and independent of the FDA.