510(k) · Cleared
ClearedVectec Disposable Trocars and Laparoscopic Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vectec · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 6, 2007 as substantially equivalent to K994066 (Mtp Medical Technical Promotion GmbH, 2000) and 3 other predicates after a 51-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it.
- Decided
- Sep 6, 2007
- Review
- 51 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K932648 (1993). 8 ancestors in all, the oldest K903206 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 3 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 2 generations backK974066 RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 1998 · Recalled
- 1 generation backK981389 Disposable RE-New ForcepsMicroline Pentax, Inc. · 1998 · Recalled
- This deviceK071976 Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007
- Descendant · cites it directly · 1 of its ownK101937 Hybrid Trocar SystemAesculap, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK153126 da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK081398 Advanced Medical Innovations Disposable Trocars and Laparoscopic…Advanced Medical Innovations, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K101937Hybrid Trocar SystemAesculap, Inc. · 2010 · cites it directly1descendant
- K153126da Vinci Xi Hasson ConeIntuitive Surgical, Inc. · 2015 · 2 generations on0descendants
- K081398Advanced Medical Innovations Disposable Trocars and Laparoscopic AccessoriesAdvanced Medical Innovations, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −3 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −2 | K974066 | RE-New Forceps Laparoscopic Surgical Tips | Microline Pentax, Inc. | 1998 | 1 |
| −1 | K981389 | Disposable RE-New Forceps | Microline Pentax, Inc. | 1998 | 6 |
| 0 (this device) | K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | Vectec | 2007 | — |
| +1 | K101937 | Hybrid Trocar System | Aesculap, Inc. | 2010 | 5 |
| +2 | K153126 | da Vinci Xi Hasson Cone | Intuitive Surgical, Inc. | 2015 | — |
| +1 | K081398 | Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories | Advanced Medical Innovations, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K994066 | MTP Disposable TrocarsSummary page 2…SUMMARY OF SAFETY AND EFFECTIVENESS (Continued) 3. PREDICATE DEVICES Trocars MTP Disposable Trocars MTP Medical Technical K994066 Promotion GMBH… | 2000 |
| * | K062169 | Applied Laparoscopic Disposable Monopolar ScissorsSummary page 2…(manufactured by VECTEC) Scissors Applied Laparoscopic Disposable Applied Medical Resources K062169 Monopolar Scissor Corporation Forceps and Disposable Re-New Forceps… | 2006 |
| * | K981389 | Disposable RE-New ForcepsSummary page 2…s K062169 Monopolar Scissor Corporation Forceps and Disposable Re-New Forceps Microline Pentax, Inc. K981389 Dissectors Hook "Re-New" Laparoscopic Instruments Microline Pentax, Inc. K962119… | 1998 |
| * | K962119 | RE-New Laparoscopic InstrumentsSummary page 2…able Re-New Forceps Microline Pentax, Inc. K981389 Dissectors Hook "Re-New" Laparoscopic Instruments Microline Pentax, Inc. K962119 (includes hook configuration) 4. DESCRIPTION OF THE DEVICES The VECTEC Disposable Trocars and L… | 1996 |
What descends from it? (3)
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 14 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K101937 (Aesculap, Inc., 2010) has gone furthest, with 1 descendant 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. 2007, this device’s year, is highlighted.
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 VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071976: Vectec Disposable Trocars and Laparoscopic Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071976
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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