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FDA 510(k)

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)

K-Number: K243075 · 2024-11-08

ApplicantSTERIS Corporation
Decision Date2024-11-08
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2024-11-08 under approval number K243075. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)?

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by STERIS Corporation. The 510(k) number is K243075.

When was Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) approved by the FDA?

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) received FDA 510(k) clearance on 2024-11-08, under approval number K243075.

What company makes Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)?

Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) is manufactured by STERIS Corporation.

What is the FDA product code for Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)?

The FDA product code for Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) is ODC.

Related PubMed Literature

PMID: 31423318 Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes. BMJ open gastroenterology (2019)

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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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