Identifiers
- 510(k) Number
- K162059 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EZEE RETRIEVAL is a single-use, disposable laparoscopic instrument designed to capture and retrieve tissue or organs during surgical procedures. It consists of a flexible plastic specimen bag, a metallic rim to maintain the bag's opening, an actuation rod with a thumb ring handle, and a closure string.
The device is supplied sterile and is intended for use in general and plastic surgery. It is a Class 2 device with FDA 510(k) clearance (K162059) and has a size of 4" x 5" with a volume of 230ml. Proper storage and handling are required to maintain sterility and functionality.
Frequently asked questions
What is the EZEE RETRIEVAL used for?
The EZEE RETRIEVAL is a single-use, disposable laparoscopic instrument designed to capture and retrieve tissue or organs during surgical procedures, such as those in general and plastic surgery.
Is the EZEE RETRIEVAL sterile and single-use?
Yes, the device is supplied sterile and is intended for single-use only to maintain sterility and prevent cross-contamination during surgical procedures.
What are the dimensions and volume of the EZEE RETRIEVAL?
The EZEE RETRIEVAL has a size of 4" x 5" and a volume of 230ml, making it suitable for capturing a variety of tissue specimens.
How is the EZEE RETRIEVAL supplied and what is its regulatory status?
The device is supplied sterile and has FDA 510(k) clearance (K162059). It is a Class 2 device intended for use in general and plastic surgery.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EZEE RETRIEVAL (K162059) — FDA 510(k) | Innolitics, Ezee Retrieval by Genicon, Inc | FDA 510 (k) Summary, K180579 FDA 510 (k) - Ezee Retrieval | Genicon, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162059 | Class II | Active |
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Manufacturer
- Manufacturer
- Genicon, Inc.
Sources (1)
- FDA 510(k) K162059 24 fields · synced Sep 27, 2026