510(k) · Cleared
ClearedAdvanced Medical Innovations Disposable Trocars and Laparoscopic Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Innovations, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 6, 2009 as substantially equivalent to K071976 (Vectec, 2007) and 7 other predicates after a 263-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Feb 6, 2009
- Review
- 263 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 5 generations to K932648 (1993). 14 ancestors in all, the oldest K903206 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK932648 Quick Switch Laparoscopic InstrumentsMicroline Pentax, Inc. · 1993
- 4 generations backK962119 RE-New Laparoscopic InstrumentsMicroline Pentax, Inc. · 1996 · Recalled
- 3 generations backK974066 RE-New Forceps Laparoscopic Surgical TipsMicroline Pentax, Inc. · 1998 · Recalled
- 2 generations backK981389 Disposable RE-New ForcepsMicroline Pentax, Inc. · 1998 · Recalled
- 1 generation backK071976 Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007
- This deviceK081398 Advanced Medical Innovations Disposable Trocars and Laparoscopic…Advanced Medical Innovations, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932648 | Quick Switch Laparoscopic Instruments | Microline Pentax, Inc. | 1993 | — |
| −4 | K962119 | RE-New Laparoscopic Instruments | Microline Pentax, Inc. | 1996 | 2 |
| −3 | K974066 | RE-New Forceps Laparoscopic Surgical Tips | Microline Pentax, Inc. | 1998 | 1 |
| −2 | K981389 | Disposable RE-New Forceps | Microline Pentax, Inc. | 1998 | 6 |
| −1 | K071976 | Vectec Disposable Trocars and Laparoscopic Accessories | Vectec | 2007 | — |
| 0 (this device) | 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 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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? (9)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071976 | Vectec Disposable Trocars and Laparoscopic AccessoriesSummary page 2…and Comparison: Device Predicate Device 510(k) Comparison Description Number American VECTEC Bioparc, K071976 Both our subject device Medical France. VECTEC and the predicate Innovations Disposable Tro… | 2007 |
| * | K040295 | Applied Laparoscopic Monopolar ScissorsSummary page 2…copic their basic Trocars and Accessories characteristics. Laparoscopic Accessories Scissors, Applied Medical K040295 & The predicate device is Forceps, Resources Corp. K062169 basically identical to our Dissectors,… | 2004 |
| * | K062169 | Applied Laparoscopic Disposable Monopolar ScissorsSummary page 2…characteristics. Laparoscopic Accessories Scissors, Applied Medical K040295 & The predicate device is Forceps, Resources Corp. K062169 basically identical to our Dissectors, subject device with the Hook,… | 2006 |
| * | K940439 | Gleeson Flovac Handcontrolled Suction Irrigation InstrumentSummary page 2…sed Babcock on physician's preference Suction Conmed. Gleeson K940439 The subject device(s) Irrigation Set FIoVac Hand are basically identical to controlled… | 1994 |
| Kept off the family tree | K971837 | FDA’s K971837 is Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820 Our reading of the summary gave K971837, FDA’s number for Verres Needle, Cannula for M820, Cannula W/Trumpet Valve… (CooperSurgical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Northgate Technologies, Inc Veress Needle”. Kept off the family tree. Summary page 2…characteristics and function. Veress Northgate K971837 The predicate device is Needles Technologies, Inc basically identical to the Veress Ne… | 1997 |
| * | K020428 | Endopath Dilating Tip Trocar, Model #512XDSummary page 2…Technologies, Inc basically identical to the Veress Needle subject device. Dilating Tip Ethicon Endo- K020428 Both our subject device Trocars, Surgery Inc - and the predicate Autoshield ENDOPATH Troca… | 2002 |
| * | K904907 | Endopath Disposable Surgical Trocar ReducerSummary page 2…PATH Trocar device are basically Trocars and identical. Hasson Trocars Flip Top Ethicon, Inc. K904907 Both our subject device Reducer Endopath and the predicate (Disposable… | 1991 |
| * | K964450 | Secondary Trocar and Sleeve with Insufflation PortSummary page 2…device are basically Surgical Trocar identical. Reducer Secondary Pilling Weck K964450 Both our subject device Trocar Secondary Trocar and the predicate with a plast… | 1997 |
| * | K992361 | Pall Surgiclear Laparoscopic Smoke Filtration System, Model CLSF1Summary page 3…Page 2 of 5 J----- I 3--3 6-9 Smoke Filter Pall Medical K992361 Both our subject device Laparoscopic and the predicate Smoke Filtrati… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K071976.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Advanced Medical Monopolar Scissors, Maryland Dissecting Forceps, Lap Clinch, Rat Tooth LapClinch, Babcock, Straight Grasping Forceps with Ratchet are indicated for use in gynecological and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their…
Read the full statement (351 words)
The Advanced Medical Monopolar Scissors, Maryland Dissecting Forceps, Lap Clinch, Rat Tooth LapClinch, Babcock, Straight Grasping Forceps with Ratchet are indicated for use in gynecological and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators
The Advanced Medical Reducer has application in gynecologic laparoscopy and other abdominal procedures and is designed to be used with the Advanced Medical Disposable Surgical Trocar to allow the surgeon to insert undersized instruments through the Trocar without losing insufflation.
The Advanced Medical Laparoscopic Smoke Filter is intended for the filtration of contaminants from smoke, generated during laparoscopic surgery, which can contain volatile organic products of combustion (including those which are perceived as odor) and particulates (including cellular debris, bacteria and viruses).
The Advanced Medical Hasson Trocar and Dilating Tip Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.
The Advanced Medical Shielded Trocar has application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments. Instruments provided with a stopcock are intended for insufflation of the operative space when the trocar is in place.
The Advanced Medical Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down (lap approach).
The Secondary Trocar is used in endoscopic surgery (abdominal and thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laparoscopes and probes. There is a seal on the cap which closes the port of entry.
The Advanced Medical Stainless Steel Veress Needle is for the initial induction of pneumoperitoneum.
The Advanced Medical Suction/Irrigation Set is intended for use in endoscopic procedures such as laparoscopy, pelviscopy, and thorascopy, for suctioning of large clots, retrieving spilled stones, high flow irrigation and hydro-dissection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081398: Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081398
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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