# K102686: Myosure Rod Lens Scope Seals

- Pathway: 510(k) (Special)
- Applicant: Interlace Medical, Inc.
- Decided: Oct 15, 2010 after 28 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954050 (1995). 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)
- K091465: Myosure Rod Lens Hysteroscope, Interlace Medical, Inc. (2009) Summary page 1.

## Indications for use
MyoSure™ Single Use Seals are a component /accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure ™ Rod Lens Hysteroscope and removable outflow channel.

Source page: https://510kreport.com/device/K102686
Methodology: https://510kreport.com/methodology