# K012603: Reprocessed Autosuture Unipolar Laparoscopic/Endoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Nov 7, 2001 after 86 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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/K012603
Methodology: https://510kreport.com/methodology