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FDA 510(k)

PAL Aspiration System

K-Number: K242804 · 2024-12-30

ApplicantMicroaire Surgical Instruments, LLC
Decision Date2024-12-30
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PAL Aspiration System is a medical device manufactured by Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2024-12-30 under approval number K242804. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAL Aspiration System?

PAL Aspiration System is a medical device that received FDA 510(k) clearance on 2024-12-30. It is manufactured by Microaire Surgical Instruments, LLC. The 510(k) number is K242804.

When was PAL Aspiration System approved by the FDA?

PAL Aspiration System received FDA 510(k) clearance on 2024-12-30, under approval number K242804.

What company makes PAL Aspiration System?

PAL Aspiration System is manufactured by Microaire Surgical Instruments, LLC.

What is the FDA product code for PAL Aspiration System?

The FDA product code for PAL Aspiration System is QPB.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Microaire Surgical Instruments, LLC

K171286PAL Multi-Use Cannulas and PAL Manual Wand K181819SMARTRELEASE Endoscopic Soft Tissue Release System K220318PAL Infiltration System K212024PAL System K243589PAL Sterilization Case K244026PAL 7020 Console

View all 7 devices →

Related Devices (Code: QPB)

K161722VITRUVIAN ULTIMATE ASPIRATORBlack & Black Surgical, Inc. K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC K170629VITRUVIAN INFILTRATION PUMPBlack & Black Surgical, Inc. K170329Basic, Dominant FlexModela AG K190551VASERlipo SystemSolta Medical K190555PowerX Lipo SystemSolta Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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