510(k) · Cleared
ClearedEnsizor Monopolar Endoscopic Scissors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Slater Endoscopy, LLC · KGE Forceps, Biopsy, Electric
Cleared on Jun 29, 2018 as substantially equivalent to K150939 (Slater Endoscopy, LLC, 2015) and 1 other predicate after a 163-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Jun 29, 2018
- Review
- 163 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K932648 (1993). 17 ancestors in all, the oldest K903206 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 5 generations between
- 3 generations backK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- 2 generations backK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- 1 generation backK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
- This deviceK180134 Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018
Show all 9 generations
- Root · 9 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 8 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 7 generations backK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
- 6 generations backK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- 5 generations backK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- 4 generations backK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- 3 generations backK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- 2 generations backK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- 1 generation backK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
- This deviceK180134 Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −8 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −7 | K970826 | Selecta-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1997 | — |
| −6 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| −5 | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| −4 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| −3 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| −2 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
| −1 | K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2015 | — |
| 0 (this device) | K180134 | Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 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 KGE? 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 KGE device
- #1 K251807 Single Use Electrosurgical Hemostatic Forceps…score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K150939 | Ensizor Endoscopic ScissorsSummary page 4…submitter claims substantial equivalence: The Ensizor® Monopolar Endoscopic Scissors is substantially equivalent to the Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583). (4) Description of device(s): Ensizor® Monopolar Endosco… | 2015 |
| * | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Summary page 4…izor® Monopolar Endoscopic Scissors is substantially equivalent to the Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583). (4) Description of device(s): Ensizor® Monopolar Endoscopic Scissors Cat # MES-26165 2.6 mm Monopolar… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K150939.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KGE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGE
184in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGE
No recall names KGE since 2007.
Adverse event reports per year · KGE
10in 2025
MAUDE reports naming product code KGE, 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 | 4 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 75 |
| 2010 | 1 | — | 0 | 29 |
| 2011 | 0 | — | 0 | 51 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 102 | 0 | 9 |
| 2017 | 2 | — | 0 | 26 |
| 2018 | 3 | 184 | 0 | 26 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures..
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/K180134 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180134: Ensizor Monopolar Endoscopic Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180134
Report an extraction error
Are you the manufacturer?
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