510(k) · Cleared
ClearedOptivia Hysteroscopic Introducer, Optivia Steerable Working Channel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optivia Medical, LLC · HIH Hysteroscope (And Accessories)
Cleared on Mar 31, 2006 after a 98-day review. The FDA summary names no predicate by number.
- Decided
- Mar 31, 2006
- Review
- 98 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
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…
Read the full statement (192 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053583 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053583: Optivia Hysteroscopic Introducer, Optivia Steerable Working Channel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053583
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026