510(k) · Cleared
ClearedSelecta-Tip Laparoscopic Scissors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microline Pentax, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 28, 1997 as substantially equivalent to K962119 (Microline Pentax, Inc., 1996) after a 22-day review. Its family tree reaches back 2 generations to 1993. 11 later devices descend from it.
- Decided
- Mar 28, 1997
- Review
- 22 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932648 (1993). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 1 generation backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- This deviceK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
- Descendant · cites it directly · 10 of its ownK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- 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 · 4 generations on · 3 of its ownK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998 · cites it directly10descendants
- K014207Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002 · cites it directly8descendants
- K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006 · 2 generations on7descendants
- K090583Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009 · 3 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 |
|---|---|---|---|---|---|
| −2 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −1 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| 0 (this device) | K970826 | Selecta-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1997 | — |
| +1 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| +1 | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| +2 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| +3 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| +4 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K962119 | RE-New Laparoscopic InstrumentsSummary page 1…aparoscopic Scissors Tips C. |dentification of Predicate Device(s) The “Selecta-Tip® Laparoscopic Instruments are substantially equivalent to their predicate, “Re-New (K962119), previously cleared and currently marketed. D. Device Description The Selecta-Tip" Laparoscopic Scissors are surgical blades u… | 1996 |
What descends from it? (11)
See all 112 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 4 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K980758 (Microline Pentax, Inc., 1998) has gone furthest, with 10 descendants of its own.
- 10 other devices also cite its predicate K962119.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
“Selecta-Tip” Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
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/K970826 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970826: Selecta-Tip Laparoscopic Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970826
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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