# K193018: Surgical Direct Hand-held Laparoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Direct, Inc.
- Decided: Dec 20, 2019 after 52 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: 4 generations back to K935270 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151567: ENDOPLUS hand-held laparoscopic instruments, Endoplus (2015) Summary page 4.

## Indications for use
Surgical Direct Hand-held Laparoscopic Instruments are intended for grasping, cutting, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscope during laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.

Source page: https://510kreport.com/device/K193018
Methodology: https://510kreport.com/methodology