510(k) · Cleared
ClearedGalileo Hysteroscopes and Laparoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galileo Electro-Optics Corp. · HIH Hysteroscope (And Accessories)
Cleared on Dec 6, 1996 as substantially equivalent to K935277 (KARL STORZ Endoscopy-America, Inc., 1994) and 2 other predicates after a 177-day review. Its family tree reaches back 1 generation to 1977. 21 later devices descend from it.
- Decided
- Dec 6, 1996
- Review
- 177 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K770378 (1977). 3 ancestors in all. 21 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK770378 Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp. · 1977
- This deviceK962256 Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996
- Descendant · cites it directly · 20 of its ownK031974 Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH · 2003
- Descendant · 2 generations on · 19 of its ownK060899 Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
- Descendant · 3 generations on · 18 of its ownK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · Recalled
- Descendant · 4 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 4 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K031974Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00…Asap Endoscopic Products GmbH · 2003 · cites it directly20descendants
- K060899Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007 · 2 generations on19descendants
- K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · 3 generations on18descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 4 generations on7descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770378 | Laparoscope, Fiber Light, Palmer-Jacobs | Richard Wolf Medical Instruments Corp. | 1977 | — |
| 0 (this device) | K962256 | Galileo Hysteroscopes and Laparoscopes | Galileo Electro-Optics Corp. | 1996 | — |
| +1 | K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00… | Asap Endoscopic Products GmbH | 2003 | — |
| +2 | K060899 | Flexilux II Cystoscope and Hysteroscope | Schoelly Imaging, Inc. | 2007 | — |
| +3 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015 | 1 |
| +4 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +4 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K088270 | Karl Storz Hysteroscopes and Laparoscopes Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K935277 | Karl Storz Hopkins (KSH) I Rigid Telescope, KSH II Rigid Telescope, KSH Rigid Operating…Summary page 1…o Hysteroscopes and Laparoscopes are substantially equivalent to several legally marketed endoscopes including the Karl Storz Hysteroscopes and Laparoscopes, (K88270 and K935277) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378). Galileo Hysteroscopes and Laparoscopes 510(k) 6/11/9… | 1994 |
| * | K880314 | Hysteroscope Autonom 4992Summary page 1…to several legally marketed endoscopes including the Karl Storz Hysteroscopes and Laparoscopes, (K88270 and K935277) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378). Galileo Hysteroscopes and Laparoscopes 510(k) 6/11/96 Page D-1 K925, pr g3 4, Device Description… | 1988 |
| * | K770378 | Laparoscope, Fiber Light, Palmer-JacobsSummary page 1…egally marketed endoscopes including the Karl Storz Hysteroscopes and Laparoscopes, (K88270 and K935277) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378). Galileo Hysteroscopes and Laparoscopes 510(k) 6/11/96 Page D-1 K925, pr g3 4, Device Description The Galileo… | 1977 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00… | 2003 | 20 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K031974 (Asap Endoscopic Products GmbH, 2003) 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 Galileo Hysteroscopes are rigid endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Galileo Laparoscopes are intended for direct visualization of the organs within the peritoneum for diagnostic and surgical procedures on the female genital organs. The Galileo Laparoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.
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/K962256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962256: Galileo Hysteroscopes and Laparoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962256
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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