# K023733: Coa-Comp/M, Automated Bipolar Coagulator

- Pathway: 510(k) (Abbreviated)
- Applicant: Ingenjorsfirman Bjorn Bergdahl AB
- Decided: May 14, 2003 after 189 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
Longest line of descent: 1 generation back to K870149 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870149: Model CBC-1 Coa-Comp Anti-Sticking Biopolar Coag., Radionics, Inc. (1987) Summary page 1.
- K871077: Model CBC-1 Coa Comp Anti-Sticking Bipolar Coag., Radionics, Inc. (1987). Our reading of the summary gave K870177, FDA’s number for Endobrush (C & S Microinstruments, Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “CBC-2 Bipolar Coagulator”.

## Indications for use
Coagulation of soft tissue during surgery.

Source page: https://510kreport.com/device/K023733
Methodology: https://510kreport.com/methodology