510(k) · Cleared
Recalled · Class II · 2023Schoelly Cystoscopes/Hysteroscopes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schoelly Fiberoptic GmbH · HIH Hysteroscope (And Accessories)
Cleared on Mar 9, 2015 as substantially equivalent to K060899 (Schoelly Imaging, Inc., 2007) and 1 other predicate after a 45-day review. Its family tree reaches back 4 generations to 1977. 18 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 2015
- Review
- 45 days
- Class
- Class II
- Product code
- HIH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K770378 (1977). 13 ancestors in all. 18 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK770378 Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp. · 1977
- 3 generations backK962256 Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996
- 2 generations backK031974 Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH · 2003
- 1 generation backK060899 Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
- This deviceK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015
- Descendant · cites it directly · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK183020 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 3 of its ownK190639 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK251652 Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA…American Medical Endoscopy, Inc. · 2025
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · cites it directly7descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · cites it directly5descendants
- K183020Endosee SystemCooperSurgical, Inc. · 2019 · 2 generations on4descendants
- K190639Endosee SystemCooperSurgical, Inc. · 2019 · 3 generations on3descendants
- K251652Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope…American Medical Endoscopy, Inc. · 2025 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K770378 | Laparoscope, Fiber Light, Palmer-Jacobs | Richard Wolf Medical Instruments Corp. | 1977 | — |
| −3 | K962256 | Galileo Hysteroscopes and Laparoscopes | Galileo Electro-Optics Corp. | 1996 | — |
| −2 | K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00… | Asap Endoscopic Products GmbH | 2003 | — |
| −1 | K060899 | Flexilux II Cystoscope and Hysteroscope | Schoelly Imaging, Inc. | 2007 | — |
| 0 (this device) | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015 | — |
| +1 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +1 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +2 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
| +3 | K190639 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
| +1 | K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope… | American Medical Endoscopy, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K060899 | Flexilux II Cystoscope and HysteroscopeSummary page 4…pe (Cystoscope, Hysteroscope) FAJ — Cystoscope and accessories, flexible/rigid 21 CFR 876.1500; Class 11 HIH- Hysteroscope (and accessories) 21 CFR 884.1690; Class II K060899, Schoelly Imaging Inc., SE date March 2, 2007 Stryker Urology and Gynecology Hardware System Stryker Urology and Gynecology Hard… | 2007 |
| * | K040390 | Stryker Urology and Gynecology Hardware SystemSummary page 5…1 CFR 876.4300; Class I1 KOG- Endoscope and/or accessories 21 CFR 876.1500; Class 11 KQT - Evacuator, gastro-urology 21 CFR 876.4370; Class II Premarket Notification: K040390, Stryker Endoscopy, SE date May 17, 2004 Device Description The proposed Schoelly Cystoscopes/Hysteroscopes and Accessories com… | 2004 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161110 | ClearPetra Suction-Evacuation Sheath | 2016 | 7 |
| K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | 2017 | 5 |
| K251652 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope… | 2025 | 1 |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | 2020 | 0 |
| K170862 | Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long… | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2023 | Class II | Z-2364-2023 | Process control | There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 5 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K161110 (Well Lead Medical Co., Ltd., 2016) has gone furthest, with 7 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. 2015, 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 Schoelly Cystoscopes/Hysteroscopes and Accessories are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.
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/K150158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150158
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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