# K012598: Reprocessed Laparoscopic Electric Instuments

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Nov 7, 2001 after 89 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- 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: 2 generations back to K910831 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945975: Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps, Everest Medical Corp. (1994) Summary page 5.
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 5.

## Most influential descendants
- K031869: Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories (2003), 0 descendants of its own

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0560-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue.

Source page: https://510kreport.com/device/K012598
Methodology: https://510kreport.com/methodology