510(k) · Cleared
ClearedAuto Suture (R) Endoscopic Scissors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Oct 17, 1990 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Oct 17, 1990
- Review
- 89 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK903206 Auto Suture (R) Endoscopic ScissorsUnited States Surgical, A Division of Tyco Healthc · 1990
- Descendant · cites it directly · 13 of its ownK040295 Applied Laparoscopic Monopolar ScissorsApplied Medical Resources Corp. · 2004
- Descendant · 2 generations on · 7 of its ownK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- Descendant · 3 generations on · 4 of its ownK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK062169 Applied Laparoscopic Disposable Monopolar ScissorsApplied Medical Resources Corp. · 2006
- Descendant · 4 generations on · 3 of its ownK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K040295Applied Laparoscopic Monopolar ScissorsApplied Medical Resources Corp. · 2004 · cites it directly13descendants
- K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006 · 2 generations on7descendants
- K090583Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009 · 3 generations on4descendants
- K062169Applied Laparoscopic Disposable Monopolar ScissorsApplied Medical Resources Corp. · 2006 · 2 generations on4descendants
- K141058Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| +3 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| +2 | K062169 | Applied Laparoscopic Disposable Monopolar Scissors | Applied Medical Resources Corp. | 2006 | — |
| +4 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040295 | Applied Laparoscopic Monopolar Scissors | 2004 | 13 |
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, K040295 (Applied Medical Resources Corp., 2004) has gone furthest, with 13 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 | — |
https://510kreport.com/device/K903206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903206: Auto Suture (R) Endoscopic Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903206
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026