Reprocessed Harmonic Scalpel

FDA 510(k) K083060 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK083060

Submission

Device name
Reprocessed Harmonic Scalpel
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
October 14, 2008
Decision date
January 9, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments
Device class
Unclassified

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at…

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K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional Stryker Sustainability Solutions02/20/2024SE
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K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional Sterilmed, Inc.08/15/2019SE
K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional Sterilmed, Inc.04/15/2019SE
K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional Surgical Instrument Service and Savings, Inc.07/12/2018SE
K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional Surgical Instrument Service and Savings Inc.(Dba…07/03/2017SE
K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional Stryker Sustainability Solutions04/05/2017SE

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K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional 11/21/2016SE
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Questions and answers

When was Reprocessed Harmonic Scalpel cleared by the FDA?

Reprocessed Harmonic Scalpel (K083060) received a 510(k) decision of Substantially Equivalent on January 9, 2009, 87 days after the submission was received.

What is the product code of K083060?

The FDA product code is NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments, a Unclassified device.