Reprocessed Harmonic Shear

FDA 510(k) K132566 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK132566

Submission

Device name
Reprocessed Harmonic Shear
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
August 15, 2013
Decision date
June 14, 2014
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…

Other 510(k)s with product code NLQ

510(k)DeviceApplicantDecision
K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional Stryker Sustainability Solutions08/14/2025SE
K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special Stryker Sustainability Solutions07/03/2024SE
K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional Stryker Sustainability Solutions02/20/2024SE
K202554Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional Stryker Sustainability Solutions03/16/2021SE
K193563Medline ReNewal Reprocessed Harmonic ACE+7 ShearsNLQ · Traditional Surgical Instrument Service and Savings Inc.(Dba…08/19/2020SE
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

More from Stryker Sustainability Solutions

510(k)DeviceDecision
K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional 06/29/2026SE
K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional 10/11/2024SE
K190478Reprocessed ViewFlex™ Xtra ICE CatheterOWQ · Traditional 11/14/2019SE
K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional 08/15/2019SE
K182272Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional 04/15/2019SE
K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional 11/21/2016SE
K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional 09/20/2016SE
K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional 06/23/2016SE
K152090Reprocessed Steerable IntroducerPNE · Traditional 03/23/2016SE
K152134Reprocessed Vessel SealerNUJ · Traditional 01/15/2016SE

Questions and answers

When was Reprocessed Harmonic Shear cleared by the FDA?

Reprocessed Harmonic Shear (K132566) received a 510(k) decision of Substantially Equivalent on June 14, 2014, 303 days after the submission was received.

What is the product code of K132566?

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