510(k) · Cleared
ClearedContinuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Henke Sass Wolf of America, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Oct 13, 1999 as substantially equivalent to K954050 (KARL STORZ Endoscopy-America, Inc., 1995) after a 161-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Oct 13, 1999
- Review
- 161 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954050 (1995). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954050 ResectoscopesKARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK991563 Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike…Henke Sass Wolf of America, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK122563 Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK182006 Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK191281 Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK123330 Iogyn EndoscopeIogyn, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009 · cites it directly4descendants
- K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012 · 2 generations on2descendants
- K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc. · 2018 · 2 generations on1descendant
- K191281Omni Hysteroscope, Omni Lok cervical sealHologic, Inc. · 2019 · 3 generations on0descendants
- K123330Iogyn EndoscopeIogyn, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954050 | Resectoscopes | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode… | Henke Sass Wolf of America, Inc. | 1999 | — |
| +1 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
| +2 | K122563 | Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel | Hologic, Inc. | 2012 | — |
| +2 | K182006 | Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. | 2018 | — |
| +3 | K191281 | Omni Hysteroscope, Omni Lok cervical seal | Hologic, Inc. | 2019 | — |
| +1 | K123330 | Iogyn Endoscope | Iogyn, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
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? (8)
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 |
|---|---|---|---|
| * | K954050 | ResectoscopesSummary page 1…oper Surgical RG-27 Series Resectoscope and Accessories , Cooper Surgical HT4 Series Hysterscopes and Accessories, Karl Storz Endoscopic Hysterscopes and Accessories and K954050, Richard Wolf GmbH Hysterscopes and Accessories, Gyrus Axipoler™, Omnitech Systems Inc. Resectoscope Electrodes. Comparison of T… | 1995 |
| * | — | Henke Sass Wolf GmbH Hysteroscopes and Accessories Named without a submission number | |
| * | — | Smith & Nephew Dyonics Hysteroscopes and Accessories Named without a submission number | |
| * | — | Cooper Surgical RG-27 Series Resectoscope and Accessories Named without a submission number | |
| * | — | Cooper Surgical HT4 Series Hysteroscopes and Accessories Named without a submission number | |
| * | — | Karl Storz Endoscopic Hysteroscopes and Accessories Named without a submission number | |
| * | — | Gyrus Axipoler Named without a submission number | |
| * | — | Omnitech Systems Inc. Resectoscope Electrodes Named without a submission number |
What descends from it? (6)
2 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?
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 HENKE SASS WOLF Hysteroscopic Resectoscopes are intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. The HENKE SASS WOLF Resectoscopes and Accessories will include the Sheaths - to establish portals for visualization and surgical access and the electrode devices indicated for resection/coagulation for soft tissue and are intended for the use with the compatible resectoscopes. The Resectoscopes…
Read the full statement (121 words)
The HENKE SASS WOLF Hysteroscopic Resectoscopes are intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. The HENKE SASS WOLF Resectoscopes and Accessories will include the Sheaths - to establish portals for visualization and surgical access and the electrode devices indicated for resection/coagulation for soft tissue and are intended for the use with the compatible resectoscopes.
The Resectoscopes and Accessories are indicated for use in diagnostic examination and therapeutic surgical procedures of but not limited to: Urological and Gynecological Fields. The surgical applications may include:
Tissue Cutting, removal, and dissection as required or encountered in but not limited to:
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
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/K991563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991563: Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991563
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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