# K052759: Dan Monopolar Lap Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Dannoritzer Medizintechnik GmbH & Co. KG
- Decided: Jun 14, 2006 after 257 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K932832 (1994). 7 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043013: Miltex Laparoscopic Instruments, Miltex, Inc. (2005) Summary page 1.
- K040699: Laparoscopic Electrode, Reusable Indicator Shaft (Leris), Megadyne Medical Products, Inc. (2004) Summary page 1.

## Most influential descendants
- K081503: Aed Monopolar Lap Accessories (2008), 7 descendants of its own
- K103508: Unmiax Laparoscopic Instrument (2011), 6 descendants of its own
- K142208: Monopolar Laparascopic Accessories (2015), 1 descendant of its own
- K230621: LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes (2023), 0 descendants of its own
- K230650: Monopolar Electrode Surgical Instrument (2023), 0 descendants of its own

## Recalls of this device
- Aug 6, 2018 · Class III · Z-0062-2019: The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions

## Indications for use
DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

Source page: https://510kreport.com/device/K052759
Methodology: https://510kreport.com/methodology