Reprocessed Ultrasonic Scalpels

FDA 510(k) K043358 · Alliance Medical Corp.

Substantially Equivalent

510(k) numberK043358

Submission

Device name
Reprocessed Ultrasonic Scalpels
Applicant
Alliance Medical Corp.
Phoenix, AZ, US
Received
December 6, 2004
Decision date
June 6, 2005
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…

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K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyNLQ · Traditional Sterilmed, Inc.08/15/2019SE
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K173627Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorNLQ · Traditional Surgical Instrument Service and Savings, Inc.07/12/2018SE
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More from Stryker Sustainability Solutions

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K060648Reprocessed Phacoemulsification TipsNKX · Traditional 03/19/2007SE
K061045Reprocessed Electrophysiology CathetersNLH · Traditional 08/31/2006SE
K051438Vanguard Reprocessed Compression Garments (Hill-Rom)JOW · Traditional 04/04/2006SE
K060049Reprocessed Compression SleevesJOW · Traditional 02/24/2006SE
K060091Alliance Medical Corporation Reprocessed Compression SleevesJOW · Traditional 02/17/2006SE
K053316Reprocessed Compression SleevesJOW · Traditional 02/13/2006SE
K052918Reprocessed External Fixation DevicesKTT · Traditional 01/27/2006SE
K052603Reprocessed Daig Livewire Electrophysiology CathetersNLH · Traditional 11/16/2005SE
K052414Reprocessed Electrophysiology CatheterNLH · Traditional 11/16/2005SE
K050518Reprocessed Phacoemuisification TipsNKX · Traditional 09/23/2005SE

Questions and answers

When was Reprocessed Ultrasonic Scalpels cleared by the FDA?

Reprocessed Ultrasonic Scalpels (K043358) received a 510(k) decision of Substantially Equivalent on June 6, 2005, 182 days after the submission was received.

What is the product code of K043358?

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