PAL Sterilization Case— 510(k) K243589

Name: FDA 510(k) clearance K243589
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Substantially Equivalent

Microaire Surgical Instruments, LLC

FDA 510(k) clearance K243589 for PAL Sterilization Case, Substantially Equivalent on 2025-06-20. Applicant: Microaire Surgical Instruments, LLC. Device class: 2.

Clearance details

Applicant: Microaire Surgical Instruments, LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2024-11-20
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

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K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

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K212024 — PAL System2022-06-10
K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System2018-11-06

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