# K152400: General & Plastic Surgery Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Sontec Instruments, Inc.
- Decided: Jan 22, 2016 after 150 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K945474 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120012: Integra Jarit Video Assisted Thoracic Surgery Instruments, Integra LifeSciences Corporation (2012) Summary page 4.
- K110121: Wexler Endoscope Accessories, Microsurgical Laboratories,Inc.Dba Wexler Surgical (2011) Summary page 4.
- K945474: Scanlan (R) Thoracoscopic Scissors, Clamp, Forceps, Needle Holder, Scanlan Intl., Inc. (1994) Summary page 4.
- K925198: Kaiser NO Cannula Thoracoscopy/Laparoscopy Instr, Pilling Co. (1993) Summary page 4.

## Indications for use
Manually operated minimally invasive General & Plastic Surgery Instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, probing, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.

Source page: https://510kreport.com/device/K152400
Methodology: https://510kreport.com/methodology