# K081070: Interlace Medical Operative Hysteroscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Interlace Medical, Inc.
- Decided: Jul 23, 2008 after 99 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: 2 generations back to K971188 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224, Smith & Nephew, Inc. (2002) Summary page 1.

## Indications for use
Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K081070
Methodology: https://510kreport.com/methodology