# K081398: Advanced Medical Innovations Disposable Trocars and Laparoscopic Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Innovations, Inc.
- Decided: Feb 6, 2009 after 263 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K932648 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071976: Vectec Disposable Trocars and Laparoscopic Accessories, Vectec (2007) Summary page 2.
- K040295: Applied Laparoscopic Monopolar Scissors, Applied Medical Resources Corp. (2004) Summary page 2.
- K062169: Applied Laparoscopic Disposable Monopolar Scissors, Applied Medical Resources Corp. (2006) Summary page 2.
- K940439: Gleeson Flovac Handcontrolled Suction Irrigation Instrument, Conmedcorp (1994) Summary page 2.
- K020428: Endopath Dilating Tip Trocar, Model #512XD, Ethicon Endo-Surgery, Inc. (2002) Summary page 2.
- K904907: Endopath Disposable Surgical Trocar Reducer, ETHICON, Inc. (1991) Summary page 2.
- K964450: Secondary Trocar and Sleeve with Insufflation Port, Pilling Weck Group (1997) Summary page 2.
- K992361: Pall Surgiclear Laparoscopic Smoke Filtration System, Model CLSF1, Pall Medical (1999) Summary page 3.

## Cited in the summary but kept off the family tree
- K971837: Verres Needle, Cannula for M820, Cannula W/Trumpet Valve for M 820, CooperSurgical, Inc. (1997). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K081398
Methodology: https://510kreport.com/methodology