Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology

FDA 510(k) K133672 · Stryker Sustainability Solutions

Substantially Equivalent

510(k) numberK133672

Submission

Device name
Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology
Applicant
Stryker Sustainability Solutions
Tempe, AZ, US
Received
November 29, 2013
Decision date
May 1, 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
K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional 06/18/2026SE
K250898Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional 08/14/2025SE
K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…NLF · Traditional 10/22/2024SE
K241606Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special 07/03/2024SE
K233471Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional 02/20/2024SE
K231621Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ · Special 07/25/2023SE
K230255Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019GEI · Special 03/28/2023SE
K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)NUJ · Special 03/28/2023SE
K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…NLF · Traditional 12/04/2022SE
K220481Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)GEI · Traditional 05/25/2022SE

Questions and answers

When was Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology cleared by the FDA?

Reprocessed Harmonic Ace Shears Without Adaptive Tissue Technology (K133672) received a 510(k) decision of Substantially Equivalent on May 1, 2014, 153 days after the submission was received.

What is the product code of K133672?

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