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FDA 510(k)

InstruSafe(R) Sterilization Container

K-Number: K180528 · 2018-11-16

ApplicantSummit Medical, Inc.
Decision Date2018-11-16
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

InstruSafe(R) Sterilization Container is the device name listed in this FDA 510(k) record. The listed applicant is Summit Medical, Inc.. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K180528. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InstruSafe(R) Sterilization Container?

InstruSafe(R) Sterilization Container is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Summit Medical, Inc.. The 510(k) number is K180528.

When did InstruSafe(R) Sterilization Container receive FDA 510(k) clearance?

InstruSafe(R) Sterilization Container received FDA 510(k) clearance on 2018-11-16, under 510(k) number K180528.

Who is the listed applicant for InstruSafe(R) Sterilization Container?

The FDA 510(k) record lists Summit Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InstruSafe(R) Sterilization Container?

The FDA product code for InstruSafe(R) Sterilization Container is KCT.

Other records listing Summit Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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