510(k) · Cleared
ClearedEndosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Jul 13, 2017 as substantially equivalent to K150158 (Schoelly Fiberoptic GmbH, 2015) and 2 other predicates after a 132-day review. Its family tree reaches back 11 generations to 1993. 1 of the 54 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jul 13, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K931154 (1993). 48 ancestors in all, the oldest K770378 (1977). 5 later devices descend from it, 1 citing it directly. 1 of the 54 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations between
- 3 generations backK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- 2 generations backK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- 1 generation backK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- This deviceK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK183020 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK190639 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK200038 Endosee SystemCooperSurgical, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK254251 InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK193007 LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA…Lina Medical Aps · 2020
Show all 11 generations
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 9 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 8 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 7 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 6 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 5 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 4 generations backK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
- 3 generations backK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- 2 generations backK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- 1 generation backK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- This deviceK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope7 generations back · 1991
Most influential descendants
Showing 5 of 5 · See all- K183020Endosee SystemCooperSurgical, Inc. · 2019 · cites it directly4descendants
- K190639Endosee SystemCooperSurgical, Inc. · 2019 · 2 generations on3descendants
- K200038Endosee SystemCooperSurgical, Inc. · 2020 · 3 generations on1descendant
- K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd. · 2026 · 4 generations on0descendants
- K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording…Lina Medical Aps · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −10 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −9 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −8 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −7 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −6 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −5 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −4 | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus Acmi, Inc. | 2007 | — |
| −3 | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | Gyrus Acmi, Inc. | 2009 | — |
| −2 | K123151 | Endosee Model 8000 U-Scope | Endosee Corp | 2013 | — |
| −1 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | — |
| 0 (this device) | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +1 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
| +2 | K190639 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
| +3 | K200038 | Endosee System | CooperSurgical, Inc. | 2020 | — |
| +4 | K254251 | InnovexView (GC146-17, GC150-20, GC155-23) | Shanghai AnQing Medical Instrument Co., Ltd. | 2026 | — |
| +3 | K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope… | Lina Medical Aps | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2026 | 1 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K150158 | Schoelly Cystoscopes/Hysteroscopes and AccessoriesSummary page 4…dicate Device Information The Endosee® is substantially equivalent to the following predicates: Primary Predicate: Schoelly Cystoscope/Hysteroscope and Accessories (K150158) Additional Predicate: EndoSee U-Scope 8000 (K123151 & K132384) The predicate devices have not been subject to a design-related… | 2015 |
| * | K123151 | Endosee Model 8000 U-ScopeSummary page 4…lly equivalent to the following predicates: Primary Predicate: Schoelly Cystoscope/Hysteroscope and Accessories (K150158) Additional Predicate: EndoSee U-Scope 8000 (K123151 & K132384) The predicate devices have not been subject to a design-related recall.… | 2013 |
| * | K132384 | U-Scope 8000 System with HSC+Emb CannulaSummary page 4…lent to the following predicates: Primary Predicate: Schoelly Cystoscope/Hysteroscope and Accessories (K150158) Additional Predicate: EndoSee U-Scope 8000 (K123151 & K132384) The predicate devices have not been subject to a design-related recall.… | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183020 | Endosee System | 2019 | 4 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 7 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 48 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183020 (CooperSurgical, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K150158.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula are used to permit viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic procedures.
Generally recognized indications for diagnostic hysteroscopy include:
» Abnormal bleeding
» Infertility and pregnancy wastage
* Evaluation of abnormal hysterosalpingogram
» Intrauterine foreign body
» Amenorrhea
* Pelvic Pain
The Endosee Hysteroscope and Disposable Diagnostic (Dx) Cannula can also be used to permit viewing of the adult urinary bladder through a minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic 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/K170660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170660
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