510(k) · Cleared
ClearedEndoscopic Monopolar Scissors, Models Ems-235, Ems-165
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Endosurgery, Inc. · KGE Forceps, Biopsy, Electric
Cleared on Jun 26, 2009 as substantially equivalent to K010412 (Telemed Systems, Inc., 2001) and 1 other predicate after a 114-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it.
- Decided
- Jun 26, 2009
- Review
- 114 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K932648 (1993). 13 ancestors in all, the oldest K903206 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 5 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 4 generations backK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
- 3 generations backK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- 2 generations backK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- 1 generation backK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- This deviceK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK242923 SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip…Envision Endoscopy · 2024
- Descendant · cites it directly · 0 of its ownK180134 Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K141058Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014 · cites it directly3descendants
- K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015 · 2 generations on2descendants
- K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…Envision Endoscopy · 2024 · 3 generations on0descendants
- K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −5 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −4 | K970826 | Selecta-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1997 | — |
| −3 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| −2 | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| −1 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| 0 (this device) | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| +1 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
| +2 | K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2015 | — |
| +3 | K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture… | Envision Endoscopy | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 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 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 |
|---|---|---|---|
| * | K010412 | Flexible Endoscopic Scissors Our reading of the summary gave K011412, FDA’s number for Powder-Free Vinyl Exam Gloves (Heyuan Hongli Industries, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TeleMed Systems Flexible Endoscopic Scissors”. | 2001 |
| * | K063485 | Logic Laparoscopic ScissorsSummary page 1…ible endoscopic procedures. Predicate Devices KO1 1412 TeleMed Systems Flexible Endoscopic Scissors TeleMed Systems Inc. K063485 Logic Laparoscopic Monopolar Scissors Surgical Innovations Group Device Description The Endosc… | 2006 |
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 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K141058 (Slater Endoscopy, LLC, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K010412.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090583: Endoscopic Monopolar Scissors, Models Ems-235, Ems-165.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090583
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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