Cook Tissue Morcellator
by Cook Urological, Inc. 510(k)
Active
510(k) K925851
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925851 | Date21 May 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Cook Tissue Morcellator is an electrosurgical device classified under Electrosurgical, Cutting & Coagulation & Accessories, designed for the mechanical fragmentation of soft tissue during surgical procedures. It operates using high-speed rotation to dissect or remove tissue, facilitating minimally invasive surgical techniques. This device is intended for use in general and plastic surgery applications where precise tissue manipulation is required. Its function aligns with electrosurgical accessories that combine cutting and coagulation capabilities, though its primary mechanism relies on mechanical morcellation rather than thermal effects.
The device is supplied as a reusable medical instrument, intended for use in controlled surgical environments such as operating rooms. It is not sterile at the time of shipment but must be sterilized prior to use, adhering to standard medical device sterilization protocols. The Cook Tissue Morcellator is regulated under FDA 510(k) clearance (K910939) with a classification under GEI (General & Plastic Surgery Electrosurgical Devices). No specific MRI safety information is provided, and its use must comply with applicable surgical and regulatory guidelines. The device’s design and intended use are governed by the Substantially Equivalent (SESE) determination from the FDA’s review panel.
Other devices from Cook Urological, Inc.
Questions
AI-generated answers, 20 Sep 2026
Is the Cook Tissue Morcellator intended for use in specific types of surgeries, and how does it differ from traditional electrosurgical tools?
The Cook Tissue Morcellator is designed for mechanical fragmentation of soft tissue during minimally invasive surgical procedures, primarily in general and plastic surgery. Unlike traditional electrosurgical tools that rely on thermal effects (cutting and coagulation), this device uses high-speed rotation to dissect or remove tissue, making it suitable for precise tissue manipulation in controlled surgical environments like operating rooms.
How is the Cook Tissue Morcellator supplied, and what sterilization steps are required before use?
The device is not sterile at shipment and must be sterilized prior to use following standard medical device sterilization protocols. It is supplied as a reusable instrument, meaning it is intended for multiple uses in a clinical setting after proper cleaning and sterilization between procedures.
What regulatory pathway does the Cook Tissue Morcellator follow, and how was its equivalence to existing devices determined?
The Cook Tissue Morcellator is regulated under the FDA 510(k) clearance process, specifically under product code GEI (General & Plastic Surgery Electrosurgical Devices). Its Substantially Equivalent (SESE) determination was made by the FDA’s General Surgery (SU) Advisory Committee in 1993, confirming it meets the same performance criteria as legally marketed predicate devices.
Are there any special considerations for storage or handling of the Cook Tissue Morcellator?
While the device’s storage conditions aren’t explicitly detailed, as a reusable surgical instrument, it should be stored in a clean, dry environment to prevent contamination. Since it requires sterilization before use, it must be handled according to clinical decontamination protocols to ensure safety and functionality for repeated procedures.