510(k) · Cleared
ClearedApplied Laparoscopic 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 Mar 12, 2004 as substantially equivalent to K903206 (United States Surgical, A Division of Tyco Healthc, 1990) after a 32-day review. Its family tree reaches back 1 generation to 1990. 13 later devices descend from it.
- Decided
- Mar 12, 2004
- Review
- 32 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903206 (1990). 13 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK903206 Auto Suture (R) Endoscopic ScissorsUnited States Surgical, A Division of Tyco Healthc · 1990
- This deviceK040295 Applied Laparoscopic Monopolar ScissorsApplied Medical Resources Corp. · 2004
- Descendant · cites it directly · 7 of its ownK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- Descendant · 2 generations on · 4 of its ownK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK062169 Applied Laparoscopic Disposable Monopolar ScissorsApplied Medical Resources Corp. · 2006
- Descendant · 3 generations on · 3 of its ownK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK071976 Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006 · cites it directly7descendants
- K090583Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009 · 2 generations on4descendants
- K062169Applied Laparoscopic Disposable Monopolar ScissorsApplied Medical Resources Corp. · 2006 · cites it directly4descendants
- K141058Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014 · 3 generations on3descendants
- K071976Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903206 | Auto Suture (R) Endoscopic Scissors | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| 0 (this device) | K040295 | Applied Laparoscopic Monopolar Scissors | Applied Medical Resources Corp. | 2004 | — |
| +1 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| +2 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| +1 | K062169 | Applied Laparoscopic Disposable Monopolar Scissors | Applied Medical Resources Corp. | 2006 | — |
| +3 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
| +2 | K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | Vectec | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K903206 | Auto Suture (R) Endoscopic ScissorsSummary page 1…gical Auto Suture® Endoscopic Scissors, which is cleared to market under premarket notification K903206 INDICATIONS FOR USE: The Applied Laparoscopic Monopolar Scissors is indicated for use in gynecologic and general endoscopic pro… | 1990 |
What descends from it? (13)
See all 133 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?
- Its one ancestor has no recall.
- Of its descendants, K063485 (Surgical Innovations Plc, 2006) has gone furthest, with 7 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 Applied Laparoscopic Monopolar Scissors is indicated for use in gynecologic and general endoscopic procedures for mobilization and transection of tissues. The device with a 5rmm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040295 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040295: Applied Laparoscopic Monopolar Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040295
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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