Steripack cases and Tray Systems

Q: What is the product code of K193066?

The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.

FDA 510(k) K193066 · Avalign Technologies, Inc.

Substantially Equivalent

510(k) numberK193066

Submission

Device name: Steripack cases and Tray Systems
Applicant: Avalign Technologies, Inc.
Fort Wayne, IN, US
Received: November 4, 2019
Decision date: August 6, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.6850
Specialty: General Hospital

Other 510(k)s with product code KCT

510(k)	Device	Applicant	Decision
K253988	LiteSet TraysKCT · Traditional	Nobel Biocare AB	09/08/2026SE
K261935	Surgical and Prosthetic TraysKCT · Traditional	Dentsply Sirona, Inc.	09/04/2026SE
K253187	SteriBest® Sterilization Tray SystemKCT · Traditional	Mastel Surgical	06/18/2026SE
K260726	Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional	Institut Straumann AG	06/03/2026SE
K252854	SteriTite Container System with MediTray ProductsKCT · Traditional	Case Medical, Inc.	06/03/2026SE
K253791	PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional	DePuy Mitek, Inc.	02/26/2026SE
K251614	Stainless Steel Surgical KitsKCT · Traditional	Dentsply Sirona, Inc.	02/06/2026SE
K251756	Sterilization TraysKCT · Traditional	Paragon Implant Mfg., LLC	11/14/2025SE
K251300	Plastic Surgical KitsKCT · Traditional	Dentsply Sirona, Inc.	07/22/2025SE
K243425	Guided DAS Surgical KitKCT · Traditional	Talladium España, SL	07/22/2025SE

More from Talladium España, SL

510(k)	Device	Decision
K252982	CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional	06/18/2026SE
K250072	CONDUIT SYNFIX Evolution Secured Spacer SystemOVD · Traditional	07/10/2025SE

Questions and answers

When was Steripack cases and Tray Systems cleared by the FDA?

Steripack cases and Tray Systems (K193066) received a 510(k) decision of Substantially Equivalent on August 6, 2020, 276 days after the submission was received.

What is the product code of K193066?

The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.