# K072613: Directview, Lightguide, Model (S) 10RLL-320 Laparoscope, 10DLG-320 Disposable Light Guide for Above

- Pathway: 510(k) (Traditional)
- Applicant: Micro Invasive Technology, Inc.
- Decided: Apr 21, 2008 after 217 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
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 its predicate without a number.
- (no number) Wolf Lumina Model 8934.40: named in the summary without a submission number

## Indications for use
UROLOGY DirectView MT Endoscopes may be used by qualified physicians for imaging of a surgical site for diagnostic and surgical urology procedures. GENERAL SURGERY DirectViewTM endoscopes may be used for general diagnostic and laparoscopic surgical procedures by a qualified physician for visualization of body cavities, organs, and canals to perform various diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K072613
Methodology: https://510kreport.com/methodology