# K023566: Codman Isocool Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: May 22, 2003 after 211 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.
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) Codman Mirror Finish Bipolar Forceps: named in the summary without a submission number
- (no number) Seedling Enterprises, LLC, Cool-Tec Reusable Bipolar Electrodes: named in the summary without a submission number
- (no number) Cool-Tec Bipolar Electrodes: named in the summary without a submission number
- (no number) Link Technology Non-Stick Bipolar Forceps: named in the summary without a submission number

## Indications for use
The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing, coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures. Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

Source page: https://510kreport.com/device/K023566
Methodology: https://510kreport.com/methodology