# K060232: Trokamed GMBH Electrosurgical Instruments & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Trokamed GmbH
- Decided: Jul 12, 2006 after 163 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945975 (1994). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973341: Hook Electrode, Needle Electrode, Coagulation Button Electrode, Richard Wolf Medical Instruments Corp. (1997) Summary page 2.
- K964602: Davis Bayonet Electrodes, Valleylab, Inc. (1997) Summary page 2.
- K040699: Laparoscopic Electrode, Reusable Indicator Shaft (Leris), Megadyne Medical Products, Inc. (2004) Summary page 2.
- K042077: Bitech Bipolar Scissors, Guenter Bissinger Medizintechnik GmbH (2004) Summary page 2.
- K960757: Karl Storz Ureter Resectoscope, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 2.
- K971881: Comeg Resectoscope and Laser-Resectoscope Working Elements/Urethrotomes/Electrodes/Albarrab Deflectors, Comeg Endoscopy (1997) Summary page 2.

## Most influential descendants
- K261179: AlphaTriPart - Monopolar MIC Instruments (2026), 0 descendants of its own

## Recalls of this device
- May 30, 2014 · Class II · Z-2729-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2722-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2721-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2728-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2725-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2727-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2726-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2723-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2730-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v
- May 30, 2014 · Class II · Z-2724-2014: Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak v

## Indications for use
The Trokamed GmbH Resectoscope & Accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used. The instruments are reusable; they are intended to be cleaned, sterilized and reused.

Source page: https://510kreport.com/device/K060232
Methodology: https://510kreport.com/methodology