# K102921: Endoscopic Monopolar Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Bema-GmbH & Co. KG
- Decided: Dec 20, 2011 after 445 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: 2 generations back to K935270 (1994). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010192: Endoscopic Tube Shaft Instruments for Monoplar Coagulation, Antyllos Medizintechnik GmbH (2001) Summary page 1.
- K033249: Pajunk Modular Handle Instruments, Pajunk GmbH (2004) Summary page 2.
- K970541: Aesculap Modular Monopolar Electrodes, Aesculap, Inc. (1997) Summary page 1.
- K003717: Instruments for Laparoscopy 5 MM, 10 MM with Coloured Handle, Detachable Endodcopic Instruments 5 MM, 10MM (Handle, Shaf, Tekno Medical Optik-Chirurgie GmbH & Co. (2001) Summary page 1.

## Most influential descendants
- K171825: Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument (2018), 1 descendant of its own
- K163615: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (2017), 1 descendant of its own
- K211019: Disposable Monopolar Laparoscopic Tips and Reusable Handles (2021), 0 descendants of its own
- K182013: EasyInstruments (2019), 0 descendants of its own

## Indications for use
Endoscapic Monopolar Instruments and Accessories are used in Laparoscopic and other minimally invasive procedures for cutting, dissection, fixation and taking of biopsy samples, depending on the design of the tip. They are also intended to control bleeding by use of monapatar high-frequency electrical current.

Source page: https://510kreport.com/device/K102921
Methodology: https://510kreport.com/methodology