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FDA 510(k)

LITe BIO Delivery System

K-Number: K160978 · 2016-07-08

ApplicantStryker Corporation
Decision Date2016-07-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LITe BIO Delivery System is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2016-07-08 under approval number K160978. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITe BIO Delivery System?

LITe BIO Delivery System is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Stryker Corporation. The 510(k) number is K160978.

When was LITe BIO Delivery System approved by the FDA?

LITe BIO Delivery System received FDA 510(k) clearance on 2016-07-08, under approval number K160978.

What company makes LITe BIO Delivery System?

LITe BIO Delivery System is manufactured by Stryker Corporation.

What is the FDA product code for LITe BIO Delivery System?

The FDA product code for LITe BIO Delivery System is FMF.

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Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024)

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Related Devices (Code: FMF)

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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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