510(k) · Cleared
Recalled · Class II · 2017Disposable RE-New Forceps
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 May 29, 1998 as substantially equivalent to K974066 (Microline Pentax, Inc., 1998) after a 43-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it. It has been recalled 6 times.
- Decided
- May 29, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932648 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 2 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 1 generation backK974066 RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 1998 · Recalled
- This deviceK981389 Disposable RE-New ForcepsMicroline Pentax, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK071976 Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007
- Descendant · 2 generations on · 1 of its ownK101937 Hybrid Trocar SystemAesculap, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 0 of its ownK153126 da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK081398 Advanced Medical Innovations Disposable Trocars and Laparoscopic…Advanced Medical Innovations, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K071976Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007 · cites it directly3descendants
- K101937Hybrid Trocar SystemAesculap, Inc. · 2010 · 2 generations on1descendant
- K153126da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015 · 3 generations on0descendants
- K081398Advanced Medical Innovations Disposable Trocars and Laparoscopic AccessoriesAdvanced Medical Innovations, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −2 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −1 | K974066 | RE-New Forceps Laparoscopic Surgical Tips | Microline Pentax, Inc. | 1998 | 1 |
| 0 (this device) | K981389 | Disposable RE-New Forceps | Microline Pentax, Inc. | 1998 | — |
| +1 | K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | Vectec | 2007 | — |
| +2 | K101937 | Hybrid Trocar System | Aesculap, Inc. | 2010 | 5 |
| +3 | K153126 | da Vinci Xi Hasson Cone | Intuitive Surgical, Inc. | 2015 | — |
| +2 | K081398 | Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories | Advanced Medical Innovations, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K974066 | RE-New Forceps Laparoscopic Surgical TipsSummary page 1…Tips C. Identification of Predicate Device(s) The Disposable Re-New Forceps Laparoscopic Surgical Tips are substantially equivalent to their predicate, Re-New Forceps (K974066), previously cleared and currently marketed. D. Device Description The Disposable Re-New Forceps Laparoscopic Surgical Tips are… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | 2007 | 3 |
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-1740-2018 | Process control | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. |
| May 12, 2014 | Class II | Z-1987-2014 | Nonconforming Material/Component | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw |
| May 12, 2014 | Class II | Z-1986-2014 | Nonconforming Material/Component | Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw |
| Apr 14, 2014 | Class II | Z-1635-2014 | Nonconforming Material/Component | Grasper jaw may break when force is applied to the jaw |
| Jul 18, 2011 | Not classified | Z-3086-2011 | Packaging process control | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled… |
| Jul 18, 2011 | Not classified | Z-3085-2011 | Packaging process control | Mislabeled: ReNew product number 3262 (Long Fenestrated Grasper) was packaged and labeled as product number 3642 (Super-Atrau Fenestrated Grasper). ReNew product number 3642 (Super-Atraumatic Fenestrated Grasper) was packaged and labeled… |
The 5 latest of 6 recalls; the web page lists all.
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 1.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K071976 (Vectec, 2007) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K974066.
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?
Cutting, Grasping, and Dissecting Various Abdominal Tissue
during Endoscopic (inclusive of laparoscopic) Surgical 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/K981389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981389: Disposable RE-New Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981389
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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