# K152111: Symmetry Surgical Quad-Lock Container System

- Pathway: 510(k) (Traditional)
- Applicant: Symmetry Surgical, Inc.
- Decided: Apr 14, 2016 after 260 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K871202 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092437: Codman Sterilization Containers, Codman & Shurtleff, Inc. (2010) Summary page 12.
- K120117: Codman Quad-Lock Sterilization Container System, Codman & Shurtleff, Inc. (2012) Summary page 12.

## Indications for use
The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to: • organize and protect stainless steel, aluminum, titanium, plastic* and silicone surgical instruments that will be sterilized • allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1) • When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised • When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is intended for use with stainless steel, aluminum, titanium, plastic and silicone surgical instruments. *The use of plastic instruments has only been confirmed for steam sterilization. For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container, the recommended maximum combined weight of the single container, lid, basket/tray and basket/tray contents is defined in Table 1. For each cycle type the qualified lumen size is the minimum diameter and maximum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.

Source page: https://510kreport.com/device/K152111
Methodology: https://510kreport.com/methodology
