InstruSafe(R) Sterilization Container

Q: What is the product code of K180528?

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) K180528 · Summit Medical, Inc.

Substantially Equivalent

510(k) numberK180528

Submission

Device name: InstruSafe(R) Sterilization Container
Applicant: Summit Medical, Inc.
St. Paul, MN, US
Received: February 28, 2018
Decision date: November 16, 2018
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

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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

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K162046	MINNE TIES MMF Suture SystemDYX · Traditional	04/11/2017SE
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K142768	Instru-Safe Instrument Protection SystemKCT · Traditional	05/29/2015SE
K142630	Instru-Safe Instrument Protection SystemKCT · Traditional	12/23/2014SE
K141513	Instru-Safe Instrument Protection SystemKCT · Traditional	12/15/2014SE
K140289	Instru-Safe Instrument Protection SystemKCT · Traditional	06/27/2014SE
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Questions and answers

When was InstruSafe(R) Sterilization Container cleared by the FDA?

InstruSafe(R) Sterilization Container (K180528) received a 510(k) decision of Substantially Equivalent on November 16, 2018, 261 days after the submission was received.

What is the product code of K180528?

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.