Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2019-07-05 under approval 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. It is manufactured by Aesculap, Inc.. The 510(k) number is K182414.

When was Aesculap® SterilContainer(TM) S2 System approved by the FDA?

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

What company makes Aesculap® SterilContainer(TM) S2 System?

Aesculap® SterilContainer(TM) S2 System is manufactured by Aesculap, Inc..

What is the FDA product code for Aesculap® SterilContainer(TM) S2 System?

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

Other Devices by Aesculap, Inc.

K152960ELAN 4 Motor System K160393AdTec K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture K172850SterilContainer with PrimeLine Pro Lid K173271Aesculap Slim Clip Applier Forceps K171001Monosyn Quick Synthetic Absorbable Surgical Suture

View all 34 devices →

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

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.

↑