# K981981: Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 3, 1998 after 90 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.
47 later devices descend from it; 5 cite it directly.
0 of 48 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) Valley Lab Force 40: named in the summary without a submission number
- (no number) VNUS Medical Closure™ System: named in the summary without a submission number
- (no number) Somnus Medical Model 615: named in the summary without a submission number
- (no number) Oratec ORA-50™: named in the summary without a submission number
- (no number) Arthrocare Electrosurgery System: named in the summary without a submission number
- (no number) Wappler Electrosurgical Unit: named in the summary without a submission number
- (no number) Ximed Medical Electrode Probe: named in the summary without a submission number
- (no number) Circon Surgical Instruments: named in the summary without a submission number

## Most influential descendants
- K022008: Cardima Ablation System (2003), 25 descendants of its own
- K023291: Cobra Cooled Cardiac Surgical Probe, Model 1596X (2002), 25 descendants of its own
- K022894: Epicor Medical Ablation System (2004), 23 descendants of its own
- K040641: Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-Acc-1 (2004), 22 descendants of its own
- K051749: Cobra Surgical System (2005), 19 descendants of its own

## Indications for use
The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.

Source page: https://510kreport.com/device/K981981
Methodology: https://510kreport.com/methodology