# K043013: Miltex Laparoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Miltex, Inc.
- Decided: Mar 4, 2005 after 122 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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 K932832 (1994). 3 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021237: Coopersurgical Laparoscopic Instruments, CooperSurgical, Inc. (2003) Summary page 1.

## Most influential descendants
- K052759: Dan Monopolar Lap Accessories (2006), 8 descendants of its own
- 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

## Indications for use
The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.

Source page: https://510kreport.com/device/K043013
Methodology: https://510kreport.com/methodology