Telepack X LED
K-Number: K182696 · 2018-11-20
ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2018-11-20
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Telepack X LED is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2018-11-20 under approval number K182696. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Telepack X LED?
Telepack X LED is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K182696.
When was Telepack X LED approved by the FDA?
Telepack X LED received FDA 510(k) clearance on 2018-11-20, under approval number K182696.
What company makes Telepack X LED?
Telepack X LED is manufactured by KARL STORZ Endoscopy-America, Inc..
What is the FDA product code for Telepack X LED?
The FDA product code for Telepack X LED is FET.
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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.