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FDA 510(k)

KARL STORZ UDEL Sterilization Trays

K-Number: K201945 · 2021-02-25

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2021-02-25
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KARL STORZ UDEL Sterilization Trays is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2021-02-25 under approval number K201945. 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 KARL STORZ UDEL Sterilization Trays?

KARL STORZ UDEL Sterilization Trays is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K201945.

When was KARL STORZ UDEL Sterilization Trays approved by the FDA?

KARL STORZ UDEL Sterilization Trays received FDA 510(k) clearance on 2021-02-25, under approval number K201945.

What company makes KARL STORZ UDEL Sterilization Trays?

KARL STORZ UDEL Sterilization Trays is manufactured by Karl Storz Endoscopy America, Inc..

What is the FDA product code for KARL STORZ UDEL Sterilization Trays?

The FDA product code for KARL STORZ UDEL Sterilization Trays is KCT.

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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.

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