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FDA 510(k)

SterilContainer S2 System

K-Number: K193582 · 2020-03-17

ApplicantAesculap, Inc.
Decision Date2020-03-17
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SterilContainer S2 System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K193582. 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 SterilContainer S2 System?

SterilContainer S2 System is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is Aesculap, Inc.. The 510(k) number is K193582.

When did SterilContainer S2 System receive FDA 510(k) clearance?

SterilContainer S2 System received FDA 510(k) clearance on 2020-03-17, under 510(k) number K193582.

Who is the listed applicant for SterilContainer S2 System?

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

What is the FDA product code for SterilContainer S2 System?

The FDA product code for SterilContainer S2 System is KCT.

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Other records listing Aesculap, Inc. as applicant

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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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