Vanguard Reprocessed Ultrasonic Scalpel
FDA 510(k) K043225 · Vanguard Medical Concepts, Inc.
510(k) numberK043225
Submission
- Device name
- Vanguard Reprocessed Ultrasonic Scalpel
- Applicant
- Vanguard Medical Concepts, Inc.
Lakeland, FL, US - Received
- November 22, 2004
- Decision date
- March 22, 2005
- 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 |
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 ShearsNLQ · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 08/19/2020SE |
| 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 |
More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K053051 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 12/22/2005SE |
| K051616 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 09/06/2005SE |
| K051180 | Vanguard Reprocessed External Fixation DevicesKTT · Traditional | 07/22/2005SE |
| K051043 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 06/06/2005SE |
| K050763 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 06/01/2005SE |
| K043198 | Vanguard Reprocessed Arthroscopic WandsNUJ · Traditional | 05/27/2005SE |
| K043253 | Vanguard Reprocessed Dilating Tip and Blunt TrocarsNLM · Traditional | 04/08/2005SE |
| K043594 | Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar AccessoriesNLM · Traditional | 03/31/2005SE |
| K043315 | Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelNLQ · Traditional | 03/22/2005SE |
| K040751 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | 03/10/2005SE |
Questions and answers
When was Vanguard Reprocessed Ultrasonic Scalpel cleared by the FDA?
Vanguard Reprocessed Ultrasonic Scalpel (K043225) received a 510(k) decision of Substantially Equivalent on March 22, 2005, 120 days after the submission was received.
What is the product code of K043225?
The FDA product code is NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments, a Unclassified device.