# K963338: Unimed Suction-Irrigation Electrode and Sliding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Unimed Surgical Products, Inc.
- Decided: Oct 21, 1996 after 59 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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) Suction-Irrigation Electrodes marketed by Cabot Medical: named in the summary without a submission number
- (no number) Suction-Irrigation Electrodes marketed by American Hydro-Surgical Instruments: named in the summary without a submission number

## Most influential descendants
- K970066: Unimed Coated Laparoscopic/Arthroscopy/Suction-Irrigation Electrode (1997), 3 descendants of its own
- K020579: Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03 (2002), 1 descendant of its own
- K170703: Single Use Arthroscopic Electrode (with Pencil) (2018), 0 descendants of its own
- K132224: Unimed Surgical Coated Electrosurgical Electrodes (2013), 0 descendants of its own

## Indications for use
designed for suction/irrigation as well as cutting and coagulating of soft tissue.

Source page: https://510kreport.com/device/K963338
Methodology: https://510kreport.com/methodology