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U.S. Department of Health and Human Services

Product Classification

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Device general laparoscopic power morcellation containment system
Definition Intended for use as a bag containment system by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures.
Physical State A retractor and boot assembly with a tissue pouch/specimen bag.
Technical Method A tissue pouch is placed through a multi-instrument port to allow for containment of tissue. The pouch is insufflated to create a working space for morcellation. A laparoscopic power morcellator and a laparoscope are placed through the port and into the pouch to enable visualization of the morcellation.
Target Area Abdomen
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePZQ
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4825
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible