# K012033: Multifunction Endoscopic Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Seedling Enterprises., LLC
- Decided: Sep 20, 2001 after 83 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: 3 generations back to K912544 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000496: Evershears Bipolar Scissors, Everest Medical Corp. (2000) Summary page 1.
- K884306: Bicap Ablating Forceps Baf-7, Circon Acmi (1989) Summary page 1.
- K003587: Clearglide Precision Bipolar Device, ETHICON, Inc. (2000) Summary page 1.
- K003126: Bipolar Trigger-Flex Probe, Ellman Intl., Inc. (2001) Summary page 1.
- K992760: Select-Sutter Micro Bipolar Forceps, Select Medizintechnik Hermann Sutter GmbH (1999) Summary page 1.

## Indications for use
The MEI is a laparoscopic and endoscopic, bipolar, electrosurgical device intended for grasping, dissecting, coagulating and transecting tissue in laparoscopic and open procedures. The types of surgery indicated are: General surgery Laparoscopic procedures Endoscopic procedures Laryngeal coagulation Orthopedic coagulation Thorascopic coagulation Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization) Ear, Nose and Throat coagulation

Source page: https://510kreport.com/device/K012033
Methodology: https://510kreport.com/methodology