# K053583: Optivia Hysteroscopic Introducer, Optivia Steerable Working Channel

- Pathway: 510(k) (Traditional)
- Applicant: Optivia Medical, LLC
- Decided: Mar 31, 2006 after 98 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Optivia Hysteroscopic Introducer is used to establish and maintain distention in the uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as: Diagnostic Hysterosco Operative Hysteroscopy Infertility and Pregnancy Wastage Removal opf Submucous Fibroids and Large Polyps Abnormal Uterine Bleeding Direct Biopsy Evaluation of Abnormal Hysterosalpingogram Transection of Intrauterine Adhesions Intrauterine Foreign Body Submucous Myomectomy Amenorrhea Transection of Intrauterine Septa Pelvic Pain Endometrial Ablation The Optivia Steerable Working Channel is used only in conjunction with the Optivia Hysteroscopic Introducer to establish and maintain distention inthe uterus and provide access to the uterine cavity for hysteroscopic instruments during diagnostic and operative hysteroscopic procedures, such as: Diagnostic Hysteroscp Operative Hysteroscopy Infertility and Pregnancy Wastage Removal opf Submucous Fibroids and Large Polyps Abnormal Uterine Bleeding Direct Biopsy Evaluation of Abnormal Hysterosalpingogram Transection of Intrauterine Adhesions Intrauterine Foreign Body Submucous Myomectomy Amenorrhea Transection of Intrauterine Septa Pelvic Pain Endometrial Ablation The Optivia Steerable Working Channel aids in visualization and gives the health care professional the ability to more precisely control the position of the diagnostic or therapeutic device than is achievable without the Steerable Working Channel.

Source page: https://510kreport.com/device/K053583
Methodology: https://510kreport.com/methodology