510(k) · Cleared
Recalled · Class II · 2017RE-New Forceps Laparoscopic Surgical Tips
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 Jan 22, 1998 as substantially equivalent to K962119 (Microline Pentax, Inc., 1996) after an 87-day review. Its family tree reaches back 2 generations to 1993. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 22, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932648 (1993). 6 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 deviceK974066 RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK981389 Disposable RE-New ForcepsMicroline Pentax, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 3 of its ownK071976 Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007
- Descendant · 3 generations on · 1 of its ownK101937 Hybrid Trocar SystemAesculap, Inc. · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK171523 Monopolar Single Use Laparoscopic InstrumentGetsch+Hiller Medizintechnik GmbH · 2017
- Descendant · 4 generations on · 0 of its ownK153126 da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K981389Disposable RE-New ForcepsMicroline Pentax, Inc. · 1998 · cites it directly4descendants
- K071976Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007 · 2 generations on3descendants
- K101937Hybrid Trocar SystemAesculap, Inc. · 2010 · 3 generations on1descendant
- K171523Monopolar Single Use Laparoscopic InstrumentGetsch+Hiller Medizintechnik GmbH · 2017 · cites it directly0descendants
- K153126da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015 · 4 generations on0descendants
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) | K974066 | RE-New Forceps Laparoscopic Surgical Tips | Microline Pentax, Inc. | 1998 | — |
| +1 | K981389 | Disposable RE-New Forceps | Microline Pentax, Inc. | 1998 | 6 |
| +2 | K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | Vectec | 2007 | — |
| +3 | K101937 | Hybrid Trocar System | Aesculap, Inc. | 2010 | 5 |
| +1 | K171523 | Monopolar Single Use Laparoscopic Instrument | Getsch+Hiller Medizintechnik GmbH | 2017 | — |
| +4 | K153126 | da Vinci Xi Hasson Cone | Intuitive Surgical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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…copic Surgical Tips C. Identification of Predicate Device(s) The “Re-New Forceps” Laparoscopic Surgical Tips are substantially equivalent to their predicate, “Re-New” (K962119), previously cleared and currently marketed. D. Device Description The “Re-New Forceps” Laparoscopic Surgical Tips are an exten… | 1996 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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?
- The line of descent spans 5 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, K981389 (Microline Pentax, Inc., 1998) has gone furthest, with 4 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?
The “Re-New Forceps” Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue 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/K974066 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974066: RE-New Forceps Laparoscopic Surgical Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974066
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