510(k) · Cleared
ClearedSmith & Nephew Dyonics Microlaparoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Sep 10, 1998 after an 84-day review. The FDA summary names its predicate without a number. 118 later devices descend from it.
- Decided
- Sep 10, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
118 later devices descend from it, 1 citing it directly.
- This deviceK982149 Smith & Nephew Dyonics MicrolaparoscopeSmith & Nephew, Inc. · 1998
- Descendant · cites it directly · 117 of its ownK013165 Usa Series LaparoscopesCircon Acmi · 2002
- Descendant · 2 generations on · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
- Descendant · 4 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K013165Usa Series LaparoscopesCircon Acmi · 2002 · cites it directly117descendants
- K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · 2 generations on106descendants
- K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 3 generations on104descendants
- K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 4 generations on103descendants
- K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982149 | Smith & Nephew Dyonics Microlaparoscope | Smith & Nephew, Inc. | 1998 | — |
| +1 | K013165 | Usa Series Laparoscopes | Circon Acmi | 2002 | — |
| +2 | K091515 | Spy Scope Intra-Operative Operating System | Novadaq Technologies, Inc. | 2009 | 1 |
| +3 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
| +4 | K124031 | DA Vinci Fluorescence Imaging Vision System | Intuitive Surgical, Inc. | 2013 | — |
| +4 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 16 | 0 |
| 2026 | 18 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Richard Wolf Medical 2.0mm mini laparoscope Named without a submission number |
What descends from it? (118)
See all 1181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013165 | Usa Series Laparoscopes | 2002 | 117 |
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, K013165 (Circon Acmi, 2002) has gone furthest, with 117 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures. For use in gynecological laparoscopy the following specific indications apply: Unexplained pelvic pain (acute, chronic) Infertility work-up Tubal sterilization Diagnosis and/or…
Read the full statement (130 words)
The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.
For use in gynecological laparoscopy the following specific indications apply:
Unexplained pelvic pain (acute, chronic)
Infertility work-up
Tubal sterilization
Diagnosis and/or treatment of ectopic pregnancy
Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (less than 16 weeks gestational size)
Evaluation of congenital anomalies of the pelvic organs
Retrieval of foreign bodies
Determination of the presence and extent of pelvic endometriosis
Determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
Access to abdomen for surgical procedures such as LAVH
Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) organs
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/K982149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982149: Smith & Nephew Dyonics Microlaparoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982149
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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