510(k) · Cleared
ClearedSmith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HIH Hysteroscope (And Accessories)
Cleared on Jan 17, 2002 as substantially equivalent to K971188 (Smith & Nephew, Inc., 1997) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1997. 14 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 57 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971188 (1997). 2 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK971188 Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and…Smith & Nephew, Inc. · 1997
- This deviceK013870 Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew…Smith & Nephew, Inc. · 2002
- Descendant · cites it directly · 7 of its ownK112134 Truclear Operative HysteroscopeSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK152143 TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK190372 Aveta SystemMeditrina, Inc. · 2019
- 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K112134Truclear Operative HysteroscopeSmith & Nephew, Inc. · 2011 · cites it directly7descendants
- K152143TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSmith & Nephew, Inc. · 2015 · 2 generations on6descendants
- K190372Aveta SystemMeditrina, Inc. · 2019 · 3 generations on4descendants
- K091465Myosure Rod Lens HysteroscopeInterlace Medical, Inc. · 2009 · cites it directly4descendants
- K122563Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow ChannelHologic, Inc. · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971188 | Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual… | Smith & Nephew, Inc. | 1997 | — |
| 0 (this device) | K013870 | Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew… | Smith & Nephew, Inc. | 2002 | — |
| +1 | K112134 | Truclear Operative Hysteroscope | Smith & Nephew, Inc. | 2011 | — |
| +2 | K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C | Smith & Nephew, Inc. | 2015 | — |
| +3 | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +1 | K091465 | Myosure Rod Lens Hysteroscope | Interlace Medical, Inc. | 2009 | — |
| +2 | K122563 | Myosure XL Rod Lens Hysteroscope, Myosure XL Outlfow Channel | Hologic, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K971188 | Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual InstrumentsSummary page 1…and Accessories Common Name: Hysteroscope Classification Name: Hysteroscopes and Accessories D. Predicate Devices Smith & Nephew’s Images Hysteroscopes and Accessories K 971188 Richard Wolf’s Hysteroscopes Operating Sheath and Insert K 000673 E. Description of Device The proposed Smith & Nephew Operativ… | 1997 |
| * | K000673 | Hysteroscope Operating Sheath and Insert, Model 8988.031/.041/.231/.241Summary page 1…teroscopes and Accessories D. Predicate Devices Smith & Nephew’s Images Hysteroscopes and Accessories K 971188 Richard Wolf’s Hysteroscopes Operating Sheath and Insert K 000673 E. Description of Device The proposed Smith & Nephew Operative Hysteroscope and Accessories is a reusable surgical device that… | 2000 |
What descends from it? (14)
See all 144 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K112134 (Smith & Nephew, Inc., 2011) 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.
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 Smith & Nephew Operative Hysteroscope and accessories are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
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/K013870 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013870
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026