Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PAL Infiltration System

K-Number: K220318 · 2022-10-14

ApplicantMicroaire Surgical Instruments, LLC
Decision Date2022-10-14
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PAL Infiltration System is a medical device manufactured by Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2022-10-14 under approval number K220318. 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 Infiltration System?

PAL Infiltration System is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Microaire Surgical Instruments, LLC. The 510(k) number is K220318.

When was PAL Infiltration System approved by the FDA?

PAL Infiltration System received FDA 510(k) clearance on 2022-10-14, under approval number K220318.

What company makes PAL Infiltration System?

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

What is the FDA product code for PAL Infiltration System?

The FDA product code for PAL Infiltration System is QPB.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT03332238 Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears ACTIVE_NOT_RECRUITING

Other Devices by Microaire Surgical Instruments, LLC

K171286PAL Multi-Use Cannulas and PAL Manual Wand K181819SMARTRELEASE Endoscopic Soft Tissue Release System K212024PAL System K242804PAL Aspiration 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.

↑