Steripack cases and Tray Systems— 510(k) K193066

Name: FDA 510(k) clearance K193066
Creator: U.S. Food and Drug Administration
Published: 2020-08-06

Substantially Equivalent

Avalign Technologies, Inc.

FDA 510(k) clearance K193066 for Steripack cases and Tray Systems, Substantially Equivalent on 2020-08-06. Applicant: Avalign Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Avalign Technologies, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2019-11-04
Decision date: 2020-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Wayne, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCT

view all

K253988 — LiteSet Trays2026-09-08
K261935 — Surgical and Prosthetic Trays2026-09-04
K253187 — SteriBest® Sterilization Tray System2026-06-18
K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

More clearances from Avalign Technologies, Inc.

view all

K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18
K250072 — CONDUIT SYNFIX Evolution Secured Spacer System2025-07-10

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