Medline ReNewal Reprocessed Harmonic ACE+7 Shears
FDA 510(k) K193563 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren
510(k) numberK193563
Submission
- Device name
- Medline ReNewal Reprocessed Harmonic ACE+7 Shears
- Applicant
- Surgical Instrument Service and Savings Inc.(Dba Medline Ren
Redmond, OR, US - Received
- December 23, 2019
- Decision date
- August 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears…NLQ · Traditional | Stryker Sustainability Solutions | 08/14/2025SE |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed…NLQ · Special | Stryker Sustainability Solutions | 07/03/2024SE |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed…NLQ · Traditional | Stryker Sustainability Solutions | 02/20/2024SE |
| K202554 | Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional | Stryker Sustainability Solutions | 03/16/2021SE |
| K190610 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | Sterilmed, Inc. | 08/15/2019SE |
| K182272 | Reprocessed HARMONIC ACE+ 7 Shears with Advanced HemostasisNLQ · Traditional | Sterilmed, Inc. | 04/15/2019SE |
| K173627 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | Surgical Instrument Service and Savings, Inc. | 07/12/2018SE |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 07/03/2017SE |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional | Stryker Sustainability Solutions | 04/05/2017SE |
| K161693 | Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisNLQ · Traditional | Stryker Sustainability Solutions | 02/23/2017SE |
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| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…NLH · Traditional | 11/15/2024SE |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerNUJ · Traditional | 10/31/2018SE |
| K170955 | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional | 07/03/2017SE |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerNUJ · Traditional | 05/02/2016SE |
| K151617 | Livewire Electrophysiology CatheterNLH · Traditional | 01/22/2016SE |
Questions and answers
When was Medline ReNewal Reprocessed Harmonic ACE+7 Shears cleared by the FDA?
Medline ReNewal Reprocessed Harmonic ACE+7 Shears (K193563) received a 510(k) decision of Substantially Equivalent on August 19, 2020, 240 days after the submission was received.
What is the product code of K193563?
The FDA product code is NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments, a Unclassified device.