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510(k) K243589

PAL Sterilization Case by Microaire Surgical Instruments, LLC — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2025
Date Received
November 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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  • K220318 — PAL Infiltration System (October 14, 2022)
  • K212024 — PAL System (June 10, 2022)
  • K211297 — SMARTRELEASE Endoscopic Soft Tissue Release System (June 24, 2021)
  • K192694 — PAL Single-Use Cannulas (May 14, 2020)
  • K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System (November 6, 2018)
  • K171286 — PAL Multi-Use Cannulas and PAL Manual Wand (October 13, 2017)
  • K150779 — LipoFilter - Hospital Pack, LipoFilter - Clinic Pack (May 22, 2015)

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  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)
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