Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue

FDA 510(k) K100537 · Ascent Healthcare Solutions

Substantially Equivalent

510(k) numberK100537

Submission

Device name
Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue
Applicant
Ascent Healthcare Solutions
Phoenix, AZ, US
Received
February 25, 2010
Decision date
May 12, 2010
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 Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue cleared by the FDA?

Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue (K100537) received a 510(k) decision of Substantially Equivalent on May 12, 2010, 76 days after the submission was received.

What is the product code of K100537?

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