# K121280: Myosure Intrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Feb 8, 2013 after 284 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: 5 generations back to K844002 (1984). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 1.
- K040223: Polyvac Instrument Delivery System, Symmetry Medical USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K182052: Omni Instrument Tray (2019), 0 descendants of its own

## Indications for use
The MyoSure Instrument Tray is intended to enclose, protect, and organize the MyoSure Rod Lens Hysteroscope, MyoSure Removable Outflow Channel, and associated components during sterilization and storage. The MyoSure Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer's instructions. The MyoSure Instrument Tray has been validated for the following sterilization cycles: Prevacuum Steam: 132°C (270°F), 4 minutes exposure, 30 minutes dry time Gravity Steam: 132°C (270°F), 15 minutes exposure, 30 minutes dry time STERRAD 100S: 59% H₂O₂, Normal Cycle Setting Contents: 1 MyoSure Rod Lens Hysteroscope and accessories

Source page: https://510kreport.com/device/K121280
Methodology: https://510kreport.com/methodology