# K961695: Endo-Tech LTD., Tips

- Pathway: 510(k) (Traditional)
- Applicant: Ratio Design Lab
- Decided: Jul 1, 1996 after 61 days
- Product code: HFG (Coagulator, Laparoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- 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) Electrosurgical Attachments sold by American Hydro-Surgical: named in the summary without a submission number

## Indications for use
The Laparoscopic Unipolar Tips will serve as accessories to the Endo-Tech, Ltd, Inc.,Endo-Aid, which is an Aspiration- Irrigation Device. These tips will thread into the laparoscopic irrigation and aspiration control handle. The tips will be used during laparoscopic procedures and electrosurgical procedures.

Source page: https://510kreport.com/device/K961695
Methodology: https://510kreport.com/methodology