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FDA 510(k)

Aesculap® SterilContainer(TM) S2 System

K-Number: K182414 · 2019-07-05

ApplicantAesculap, Inc.
Decision Date2019-07-05
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Aesculap® SterilContainer(TM) 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 2019-07-05 under 510(k) number K182414. 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 Aesculap® SterilContainer(TM) S2 System?

Aesculap® SterilContainer(TM) S2 System is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Aesculap, Inc.. The 510(k) number is K182414.

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

Aesculap® SterilContainer(TM) S2 System received FDA 510(k) clearance on 2019-07-05, under 510(k) number K182414.

Who is the listed applicant for Aesculap® SterilContainer(TM) 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 Aesculap® SterilContainer(TM) S2 System?

The FDA product code for Aesculap® SterilContainer(TM) S2 System is KCT.

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Other records listing Aesculap, 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.

K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

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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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