# K230680: Anthogyr Surgical Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Anthogyr
- Decided: Jul 11, 2023 after 120 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: 8 generations back to K844002 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160730: Instrument kits, Anthogyr (2017) Summary page 5.

## Indications for use
The Anthogyr Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and protect the instruments that are sterilized by healthcare provider. The cassette is to be enclosed in an FDA cleared steam sterilizable pouch. The cassettes are not intended on their own to maintain sterility. The cycle of sterilization is: INMODOPS3, INMODOPS3L, INMODOPP3, INMODIGM, INMODOPS3V, INMODOPS3LV, INMODOPP3V, INMODIGMV: Pre-vacuum steam: 132 °C (270º F) during 4 minutes with 20 minutes drying time The Anthogyr Surgical Cassettes have been validated for a maximum load of with the associated instruments: The worst-case recommended load is 412g. The device dimensions are listed below for Anthogyr Surgical Cassettes: - INMODOPS3, INMODOPS3V, INMODOPS3L, INMODOPS3LV, INMODOPP3, INMODOPP3V: 130x155x47 mm - INMODIGM, INMODIGMV: 76x155x47 mm The cassettes are not intended to be stacked during sterilization process.

Source page: https://510kreport.com/device/K230680
Methodology: https://510kreport.com/methodology