# K103213: Finess Endoscope Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Feb 2, 2011 after 93 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: 1 generation back to K013003 (2002). 1 ancestor in all.
22 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder, Advanced Sterilization Products (2002) Summary page 2.

## Most influential descendants
- K133942: Endoscope Sterilization Tray (2014), 19 descendants of its own
- K142937: Endoscope Sterilization Tray (2015), 16 descendants of its own
- K151450: Endoscope Sterilization Tray (2016), 15 descendants of its own
- K170640: Endoscope Sterilization Tray (2017), 14 descendants of its own
- K180964: Endoscope Sterilization Tray (2018), 13 descendants of its own

## Indications for use
The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD IOONX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting. * The sterilization cycle parameters of the STERRAD sterilizers are preset by the manufacturer and are not adjustable. * The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS Endoscope and 2 light post adapters. The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Source page: https://510kreport.com/device/K103213
Methodology: https://510kreport.com/methodology