Reprocessed Cordless Ultrasonic Dissection Device

FDA 510(k) K143562 · Sterilmed, Inc.

Substantially Equivalent

510(k) numberK143562

Submission

Device name
Reprocessed Cordless Ultrasonic Dissection Device
Applicant
Sterilmed, Inc.
Maple Grove, MN, US
Received
December 16, 2014
Decision date
May 20, 2015
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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Questions and answers

When was Reprocessed Cordless Ultrasonic Dissection Device cleared by the FDA?

Reprocessed Cordless Ultrasonic Dissection Device (K143562) received a 510(k) decision of Substantially Equivalent on May 20, 2015, 155 days after the submission was received.

What is the product code of K143562?

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