# K073498: Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf System

- Pathway: 510(k) (Traditional)
- Applicant: Rudolf Medical GmbH + Co. KG
- Decided: Sep 19, 2008 after 281 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 K945975 (1994). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062047: Adaptable Monopolar Adaptable and/or Retractable Electrodes, PAJUNK GmbH Medizintechnologie (2006) Summary page 2.
- K051429: Claris Non-Stick Bipolar Forceps, Guenter Bissinger Medizintechnik GmbH (2005) Summary page 2.
- K042077: Bitech Bipolar Scissors, Guenter Bissinger Medizintechnik GmbH (2004) Summary page 2.
- K010112: Bipolar Coagulation System, Enable Medical Corp. (2001) Summary page 2.
- K001330: Sovereign Bipolar Instruments, Aesculap, Inc. (2000) Summary page 2.

## Indications for use
Rudolf's laparoscopic and electrosurgical instruments are designed for dissecting, cutting and optional monopolar or bipolar coagulation of tissue during general surgical procedures. These devices have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Source page: https://510kreport.com/device/K073498
Methodology: https://510kreport.com/methodology