# K023288: Cobra Bipolar Clamp, Model 15902

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific EP Technologies
- Decided: Apr 2, 2003 after 182 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: 3 generations back to K921884 (1992). 8 ancestors in all.
46 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013873: Cobra Cardiac Electrosurgical System, Boston Scientific Corp (2002). Our OCR of the scanned summary read K013783, FDA’s number for Aution Max AX-4280 Urinalysis System (International Remote Imaging Systems). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Cobra Electrosurgical Probe”.

## Most influential descendants
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own
- K053436: Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console (2006), 22 descendants of its own
- K043579: Atricure Bipolar System (2007), 18 descendants of its own
- K082074: Atricure CRYO1 Cryo-Ablation Probe (2009), 16 descendants of its own
- K111042: Atricure Cryo Module (2011), 14 descendants of its own

## Indications for use
The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis,

Source page: https://510kreport.com/device/K023288
Methodology: https://510kreport.com/methodology