# K012625: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Oct 22, 2001 after 70 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: 2 generations back to K910831 (1991). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984240: Endopath Endoscopic Instruments, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K934784: Endopath Endoscopic Electrosurgical Forceps with Cutting Feature, ETHICON, Inc. (1994) Summary page 1.
- K930933: Endopath Endoscopic Surgical Instruments, ETHICON, Inc. (1993) Summary page 1.

## Most influential descendants
- K240334: LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D,  DI-5731-33D, DI-5731-45D,  DI-5901-33D, DI-5901-45D) (2024), 0 descendants of its own
- K031869: Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories (2003), 0 descendants of its own

## Indications for use
Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.

Source page: https://510kreport.com/device/K012625
Methodology: https://510kreport.com/methodology