510(k) · Cleared
ClearedHysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HIH Hysteroscope (And Accessories)
Cleared on May 26, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- May 26, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK000673 Hysteroscope Operating Sheath and Insert, Model…Richard Wolf Medical Instruments Corp. · 2000
- Descendant · cites it directly · 14 of its ownK013870 Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew…Smith & Nephew, Inc. · 2002
- Descendant · 2 generations on · 7 of its ownK112134 Truclear Operative HysteroscopeSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 6 of its ownK152143 TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK091465 Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K013870Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow…Smith & Nephew, Inc. · 2002 · cites it directly14descendants
- K112134Truclear Operative HysteroscopeSmith & Nephew, Inc. · 2011 · 2 generations on7descendants
- K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc. · 2015 · 3 generations on6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 4 generations on4descendants
- K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000673 | Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241 | Richard Wolf Medical Instruments Corp. | 2000 | — |
| +1 | K013870 | Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew… | Smith & Nephew, Inc. | 2002 | — |
| +2 | K112134 | Truclear Operative Hysteroscope | Smith & Nephew, Inc. | 2011 | — |
| +3 | K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | Smith & Nephew, Inc. | 2015 | — |
| +4 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +2 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 162 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?
- Of its descendants, K013870 (Smith & Nephew, Inc., 2002) has gone furthest, with 14 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 | — |
https://510kreport.com/device/K000673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000673: Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000673
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026