510(k) · Cleared
Recalled · Class II · 2017RE-New Laparoscopic Instruments
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 Aug 9, 1996 as substantially equivalent to K932648 (Microline Pentax, Inc., 1993) after a 70-day review. Its family tree reaches back 1 generation to 1993. 31 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 9, 1996
- Review
- 70 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932648 (1993). 31 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- This deviceK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996
- Descendant · cites it directly · 11 of its ownK970826 Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997
- Descendant · 2 generations on · 10 of its ownK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- Descendant · 2 generations on · 8 of its ownK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- Descendant · 3 generations on · 7 of its ownK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- Descendant · cites it directly · 6 of its ownK974066 RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 1998 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K970826Selecta-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1997 · cites it directly11descendants
- K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998 · 2 generations on10descendants
- K014207Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002 · 2 generations on8descendants
- K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006 · 3 generations on7descendants
- K974066RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 1998 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| 0 (this device) | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | — |
| +1 | K970826 | Selecta-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1997 | — |
| +2 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| +2 | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| +3 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| +1 | K974066 | RE-New Forceps Laparoscopic Surgical Tips | Microline Pentax, Inc. | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K932648 | Quick Switch Laparoscopic InstrumentsSummary page 1…aparoscopic Instruments C. |dentification of Predicate Device(s) The “Re-New" Laparoscopic Instruments are substantially equivalent to their predicate, “Quick Switch” (K932648, previously cleared and currently marketed. D. Device Description The Re-New” Laparoscopic Scissors are surgical instruments us… | 1993 |
What descends from it? (31)
See all 3111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970826 | Selecta-Tip Laparoscopic Scissors | 1997 | 11 |
| K974066 | RE-New Forceps Laparoscopic Surgical Tips | 1998 | 6 |
| K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | 2007 | 3 |
| K030890 | Switchblade | 2003 | 3 |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece… | 2020 | 2 |
| K160706 | ReNew V Handpiece Laparoscopic Instruments | 2016 | 2 |
| K213127 | ReNew Disposable Scissor Tips | 2022 | 1 |
| K182013 | EasyInstruments | 2019 | 0 |
| K103726 | Jarit Take-Apart Endoscopic Instruments | 2012 | 0 |
| K072811 | Marionette SA, Model 001 001 & 001 002 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2017 | Class II | Z-1741-2018 | Process control | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. |
| Jul 13, 2017 | Class II | Z-0507-2018 | Device Design | The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K970826 (Microline Pentax, Inc., 1997) has gone furthest, with 11 descendants of its own.
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?
The “Quick Switch” and “Re-New” are intended for use 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/K962119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962119: RE-New Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962119
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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