# K090979: Disposable Handle Assembles, Models DH0100 and DH0500 Series

- Pathway: 510(k) (Traditional)
- Applicant: Encision, Inc.
- Decided: May 28, 2009 after 51 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) Shielded Laparoscopic Monopolar Electrodes: named in the summary without a submission number
- (no number) “Take Apart®” Insulated Forceps, Biopsy Forceps, Scissors: named in the summary without a submission number
- (no number) Laparoscopic Scissors: named in the summary without a submission number
- (no number) Endopath Endoscopic Instruments: named in the summary without a submission number

## Indications for use
The Encision Disposable Handle Assemblies are used for minimally invasive surgical, laparoscopic and endoscopic procedures performed in general surgery, obstetrics/gynecology and gastroenterology/urology.

Source page: https://510kreport.com/device/K090979
Methodology: https://510kreport.com/methodology