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FDA 510(k)

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

K-Number: K190610 · 2019-08-15

ApplicantSterilmed, Inc.
Decision Date2019-08-15
Product CodeNLQ
DecisionSubstantially Equivalent

Device Summary

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is a medical device manufactured by Sterilmed, Inc.. It received FDA 510(k) clearance on 2019-08-15 under approval number K190610. The device is classified under product code NLQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is a medical device that received FDA 510(k) clearance on 2019-08-15. It is manufactured by Sterilmed, Inc.. The 510(k) number is K190610.

When was Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology approved by the FDA?

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology received FDA 510(k) clearance on 2019-08-15, under approval number K190610.

What company makes Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is manufactured by Sterilmed, Inc..

What is the FDA product code for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology?

The FDA product code for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology is NLQ.

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Related Devices (Code: NLQ)

K151405Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue TechnologySurgical Instrument Services and Savings(Dba Medline Renewal K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions K161693Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings, Inc. K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisSterilmed, 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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