510(k) · Cleared
ClearedMicrospan Hysteroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imagyn Medical, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Oct 15, 1996 after a 167-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Oct 15, 1996
- Review
- 167 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 4 citing it directly.
- This deviceK961688 Microspan HysteroscopeImagyn Medical, Inc. · 1996
- Descendant · cites it directly · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- Descendant · 2 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- Descendant · 2 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK202445 Hystero-V HysteroscopeHysterovue, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK183020 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · cites it directly20descendants
- K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 2 generations on19descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 2 generations on5descendants
- K202445Hystero-V HysteroscopeHysterovue, Inc. · 2021 · 3 generations on4descendants
- K183020Endosee SystemCooperSurgical, Inc. · 2019 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961688 | Microspan Hysteroscope | Imagyn Medical, Inc. | 1996 | — |
| +1 | K123151 | Endosee Model 8000 U-Scope | Endosee Corp | 2013 | — |
| +2 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | — |
| +2 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +3 | K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | 2021 | — |
| +3 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Imagyn Hysteroscope Named without a submission number | |
| * | — | Imagyn MicroLap Laparoscope Named without a submission number | |
| * | — | Karl Storz Miniscope Straight Forward Telescope Named without a submission number | |
| * | — | Optimed Technologies Rigid Fiber Optic Hysteroscope Named without a submission number |
What descends from it? (24)
See all 244 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K123151 (Endosee Corp, 2013) has gone furthest, with 20 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 MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961688 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961688: Microspan Hysteroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961688
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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