# K123175: Detachatip Iii Plus Instrument Tray Model 3-4343

- Pathway: 510(k) (Abbreviated)
- Applicant: Conmed Corporation
- Decided: Feb 21, 2013 after 135 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: 6 generations back to K844002 (1984). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092414: Conmed Detachatip Instrument Tray, 33CM and 43CM, Conmed Corporation (2010) Summary page 1.

## Indications for use
DetachaTip@ III Plus Multi-Use Instrument Tray (REF 3-4343) is a reusable sterilization tray intended for pre-vacuum steam sterilization, organization, transportation, and storage of enclosed, reusable medical devices. DetachaTip® 111 Plus Multi-Use Instrument Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. DetachaTip'!) III Plus Multi-Use Instrument Tray is intended for use with DetachaTiptV III instruments and ConMed reusable medical devices meeting challenge conditions defined in Table 1. The MAXIMUM recommended load is: 25 lb [11.3 kg]. Table 1 - Reusable Medical Device Challenge Conditions Minimum Maximum Inner Diameter Length 5min 45 cm 3 mm 32 cm Sterilize the DctachaTip@ III Plus Multi-Use Instrument Tray using the following parameters: .Method Cycle Temperature Exposure Time Dry Cycle Time Steam (wrapped) Pre-vacuum 2700 F(1320 C) 4 minutes 30 minutes The devices should be sterilized using an FDA cleared wrap indicated for these sterilization cycles. Allow for a 30 minute cool down prior to handling.

Source page: https://510kreport.com/device/K123175
Methodology: https://510kreport.com/methodology