510(k) · Cleared
ClearedSmith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual Instruments
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 Jun 27, 1997 after an 88-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Jun 27, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK971188 Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and…Smith & Nephew, Inc. · 1997
- 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 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · 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) | K971188 | Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual… | Smith & Nephew, Inc. | 1997 | — |
| +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 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Karl Storz Endoscopy Telescopes and accessories Named without a submission number | |
| * | — | Henke-Sass Wolf Hysteroscopes and accessories Named without a submission number | |
| * | — | Circon ACMI Semi-rigid and Flexible Manual Instruments Named without a submission number | |
| * | — | Richard Wolfe Semi-rigid and Flexible Manual Instruments Named without a submission number |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013870 | Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow… | 2002 | 14 |
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 | — |
What is it indicated for?
Smith & Nephew Images Hysteroscopes and accessories are used to permit viewing of the cervial canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for endoscopic examination and treatment of the ceriveal canal and uterine cavity.
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/K971188 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971188: Smith & Nephew Images Endoscopes and Accessoris/Semi-Rigid and Flexible Manual Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971188
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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