510(k) · Cleared
ClearedApplied Laparoscopic Disposable Monopolar Scissors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Aug 24, 2006 as substantially equivalent to K040295 (Applied Medical Resources Corp., 2004) after a 24-day review. Its family tree reaches back 2 generations to 1990. 4 later devices descend from it.
- Decided
- Aug 24, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903206 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK903206 Auto Suture (R) Endoscopic ScissorsUnited States Surgical, A Division of Tyco Healthc · 1990
- 1 generation backK040295 Applied Laparoscopic Monopolar ScissorsApplied Medical Resources Corp. · 2004
- This deviceK062169 Applied Laparoscopic Disposable Monopolar ScissorsApplied Medical Resources Corp. · 2006
- Descendant · cites it directly · 3 of its ownK071976 Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007
- Descendant · 2 generations on · 1 of its ownK101937 Hybrid Trocar SystemAesculap, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 0 of its ownK153126 da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK081398 Advanced Medical Innovations Disposable Trocars and Laparoscopic…Advanced Medical Innovations, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K071976Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007 · cites it directly3descendants
- K101937Hybrid Trocar SystemAesculap, Inc. · 2010 · 2 generations on1descendant
- K153126da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015 · 3 generations on0descendants
- K081398Advanced Medical Innovations Disposable Trocars and Laparoscopic AccessoriesAdvanced Medical Innovations, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903206 | Auto Suture (R) Endoscopic Scissors | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −1 | K040295 | Applied Laparoscopic Monopolar Scissors | Applied Medical Resources Corp. | 2004 | — |
| 0 (this device) | K062169 | Applied Laparoscopic Disposable Monopolar Scissors | Applied Medical Resources Corp. | 2006 | — |
| +1 | K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | Vectec | 2007 | — |
| +2 | K101937 | Hybrid Trocar System | Aesculap, Inc. | 2010 | 5 |
| +3 | K153126 | da Vinci Xi Hasson Cone | Intuitive Surgical, Inc. | 2015 | — |
| +1 | K081398 | Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories | Advanced Medical Innovations, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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 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 |
|---|---|---|---|
| * | K040295 | Applied Laparoscopic Monopolar ScissorsSummary page 1…e Monopolar Scissors PREDICATE DEVICE: Applied Laparoscopic Monopolar Scissor (K040295) INTENDED USE: The Applied Laparoscopic Monopolar Scissors is intended for use in general and gynecologic endoscopic procedures… | 2004 |
What descends from it? (4)
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071976 (Vectec, 2007) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K040295.
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 Applied Laparoscopic Monopolar Scissors is indicated for use in patients undergoing general, gynecologic and urologic endoscopic procedures for mobilization and transection of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062169 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062169: Applied Laparoscopic Disposable Monopolar Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062169
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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