510(k) · Cleared
ClearedGyrus Acmi Invisio Digital Hysteroscope, Model Idh-4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Sep 29, 2009 as substantially equivalent to K060269 (Acmi Corporation, 2006) and 3 other predicates after a 63-day review. Its family tree reaches back 8 generations to 1993. 1 of the 52 devices in its family, counting itself, has a Class I recall. 22 later devices descend from it.
- Decided
- Sep 29, 2009
- Review
- 63 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K931154 (1993). 29 ancestors in all, the oldest K791182 (1979). 22 later devices descend from it, 3 citing it directly. 1 of the 52 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 4 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 3 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 2 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 1 generation backK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
- This deviceK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- 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 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope5 generations back · 1991
Most influential descendants
Showing 5 of 22 · 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 |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −4 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −3 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −2 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −1 | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus Acmi, Inc. | 2007 | — |
| 0 (this device) | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | Gyrus Acmi, Inc. | 2009 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (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 |
|---|---|---|---|
| * | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemSummary page 2…eatures included in the predicate Gyrus ACMI Invisio Digital, IPN-2505 Percutaneous Nephroscope K072594, and the ACMI DUR®-Digital Ureteroscope & Choledochoscope, DUR®-D K060269. The proposed device incorporates the same CMOS video imaging technology located in the endoscope as the aforementioned Invisio p… | 2006 |
| * | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemSummary page 2…uivalence The Gyrus ACMI® Invisio® Digital Hysteroscope System, utilizes features included in the predicate Gyrus ACMI Invisio Digital, IPN-2505 Percutaneous Nephroscope K072594, and the ACMI DUR®-Digital Ureteroscope & Choledochoscope, DUR®-D K060269. The proposed device incorporates the same CMOS video i… | 2007 |
| * | K990411 | MVM 7.5 French Flexible HysteroscopeSummary page 2…t contacting materials used in the distal tip, working channel and deflection cover. Like other predicate hysteroscopes: the Karl Storz MVM 7.5 Fr Flexible Hysteroscope (K99041 1); and the Olympus Visera HFY-V Hysterovideoscope (K022445); the proposed hysteroscope has similar shaft diameter and working leng… | 1999 |
| * | K022445 | Visera Hysterovideoscope Olympus Hyf Type VSummary page 2…nel and deflection cover. Like other predicate hysteroscopes: the Karl Storz MVM 7.5 Fr Flexible Hysteroscope (K99041 1); and the Olympus Visera HFY-V Hysterovideoscope (K022445); the proposed hysteroscope has similar shaft diameter and working length and is intended for viewing of the cervical canal and-u… | 2003 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 29 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K123151 (Endosee Corp, 2013) has gone furthest, with 20 descendants of its own.
- 6 other devices also cite its predicate K060269.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invisio TM Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image…
Read the full statement (107 words)
The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invisio TM Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.
Diagnostic Hysteroscopy:
Abnormal uterine bleeding
Infertility & pregnancy wastage
Evaluation of abnormal hysterosalpingogram
Intrauterine foreign body
Amenorrhea
Pelvic pain
Operative Hysteroscopy:
Directed biopsy
Removal of fibroids and polyps
Transection of intrauterine adhesions
Transection intrauterine septa
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092278
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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