510(k) · Cleared
ClearedStryker Urology and Gynecology Hardware System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HIH Hysteroscope (And Accessories)
Cleared on May 17, 2004 after a 90-day review. The FDA summary names its predicate without a number. 33 later devices descend from it.
- Decided
- May 17, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 7 citing it directly.
- This deviceK040390 Stryker Urology and Gynecology Hardware SystemStryker Endoscopy · 2004
- Descendant · cites it directly · 18 of its ownK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · Recalled
- Descendant · 2 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK183020 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
- Descendant · cites it directly · 4 of its ownK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · cites it directly18descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 2 generations on7descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 2 generations on5descendants
- K183020Endosee SystemCooperSurgical, Inc. · 2019 · 3 generations on4descendants
- K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040390 | Stryker Urology and Gynecology Hardware System | Stryker Endoscopy | 2004 | — |
| +1 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015 | 1 |
| +2 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +2 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +3 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
| +1 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 0 |
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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Devices and surgery systems marketed by Henke Sass Wolf Named without a submission number | |
| * | — | Devices and surgery systems marketed by Omnitech Systems Named without a submission number | |
| * | — | Devices and surgery systems marketed by GIMMI Named without a submission number | |
| * | — | Devices and surgery systems marketed by ACMI Named without a submission number |
What descends from it? (33)
See all 337 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | 2015 | 18 |
| K091465 | Myosure Rod Lens Hysteroscope | 2009 | 4 |
| K142194 | CytoSure Urinary Access System | 2014 | 2 |
| K233635 | SPY Cystoscope/Hysteroscope | 2024 | 1 |
| K173070 | HSW Resection Instruments | 2018 | 1 |
| K171336 | Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm… | 2017 | 1 |
| K252012 | SPY Cystoscope/Hysteroscope | 2025 | 0 |
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.
What does this lineage say?
- Of its descendants, K150158 (Schoelly Fiberoptic GmbH, 2015) has gone furthest, with 18 descendants of its own.
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 Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive…
Read the full statement (122 words)
The Stryker Urology and Gynecology Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures:
Dilation of the urethra, and cold-slitting of urethral strictures
Trans-urethral incision and resection of the prostate
Trans-urethral removal of bladder tumors
Trans-cervical resection and ablation of the endometrium
Trans-cervical resection of fibroids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040390: Stryker Urology and Gynecology Hardware System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040390
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026