# K212396: UroLift System Rigid Retrieval Kit Sterilization Tray

- Pathway: 510(k) (Special)
- Applicant: Neotract, Inc.
- Decided: Oct 22, 2021 after 81 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: 7 generations back to K844002 (1984). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192781: UroLift System Procedure Kit Sterilization Tray, Neotract, Inc. (2020) Summary page 5.

## Indications for use
The UroLift System Rigid Retrieval Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments optionally used for the UroLift System procedure for storage and sterilization in a prevacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Rigid Retrieval Kit Sterilization Tray: • UL-SCOPE4-0 / UL-SCOPE4-0-FE* – Cystoscope, 4.0 mm diameter x 302 mm length, 0° angle of view, wide angle • UL-GRASP-R – Optical Graspers, double action jaws • UL-SCI-R – Optical Scissors, double action jaws * Factory Exchange: Devices with a part number ending in “FE” have been repaired to meet product specifications. The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following prevacuum steam sterilization cycles: Prevacuum Steam Temperature: 132°C (270°F) Sterilization time: 4 minutes Minimum dry time: 30 minutes Maximum weight: 5 lbs (2.7 kg)

Source page: https://510kreport.com/device/K212396
Methodology: https://510kreport.com/methodology