# K233222: Aygün Sterilization Container Systems

- Pathway: 510(k) (Traditional)
- Applicant: Aygun Surgical Instruments Co., Inc.
- Decided: Dec 12, 2023 after 75 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Aygiin Sterilization Container Systems is indicated for use by hospitals and health care facilities to: • Organize and protect stainless steel, aluminum, titanium, plastic, and silicone surgical instruments during the reprocessing process, • Facilitate the sterilization of the enclosed instruments via pre-vacuum steam sterilization cycles, • 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 remains uncompromised, • The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is designed for use with stainless steel, aluminum, titanium, plastic, and silicone surgical instruments. For effective sterilization and drying of any size Aygiin Sterilization Container System, the recommended maximum combined weight of the single container, lid, basket/tray, and basket/tray contents is defined below. The qualified lumen size, representing the minimum diameter and maximum length, which has been qualified for use, is also shown below. Type: Pre-vacuum Steam Sterilization. Cycle: Temperature: 132°C, Exposure Time: 4 minutes, Drying Time: 30 minutes. Stackable: No. Instrument Type: stainless steel, aluminum, titanium, plastic, and silicone surgical instruments. Lumen Size: ≥ Full Size: 1mm x 500mm, ≤ Three Quarter Size: 1mm x 200mm Maximum Weight: ≥ Three Quarter Size: 25 lbs., ≤ Half Size 15 lbs.

Source page: https://510kreport.com/device/K233222
Methodology: https://510kreport.com/methodology