Reprocessed Ultrasonic Coagulating Shears

FDA 510(k) K093702 · Ascent Healthcare Solutions

Substantially Equivalent

510(k) numberK093702

Submission

Device name
Reprocessed Ultrasonic Coagulating Shears
Applicant
Ascent Healthcare Solutions
Phoenix, AZ, US
Received
December 1, 2009
Decision date
March 4, 2010
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
K111600Reprocessed Hand Activate Sealer/DividerNUJ · Traditional 11/15/2011SE
K110189Reprocessed Electrosurgical InstrumentNUJ · Traditional 07/18/2011SE
K100909Reprocessed Compression SleevesJOW · Traditional 07/23/2010SE
K100254Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional 05/28/2010SE
K100537Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional 05/12/2010SE
K100080Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional 03/19/2010SE
K092425Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional 10/21/2009SE
K090323Reprocessed Electrophysiology CathetersNLH · Traditional 04/01/2009SE
K082023Reprocessed Electrophysiology CathetersNLH · Traditional 09/16/2008SE
K081238Reprocessed Masimo Pulse Oximeter SensorsNLF · Traditional 07/29/2008SE

Questions and answers

When was Reprocessed Ultrasonic Coagulating Shears cleared by the FDA?

Reprocessed Ultrasonic Coagulating Shears (K093702) received a 510(k) decision of Substantially Equivalent on March 4, 2010, 93 days after the submission was received.

What is the product code of K093702?

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