# K963930: CTS Midcab/SVH Bipolar Scissors

- Pathway: 510(k) (Traditional)
- Applicant: Cardiothoracic Systems, Inc.
- Decided: Jan 16, 1997 after 107 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.
125 later devices descend from it; 5 cite it directly.
3 of 126 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) Symbiosis Bipolar Scissors: named in the summary without a submission number
- (no number) Everest Medical Bipolar Scissors: named in the summary without a submission number
- (no number) Valley Forge Bi-Tech Bipolar Coagulator/Cutting System: named in the summary without a submission number
- (no number) Valleylab Force 2 and Force 4 Electrosurgical Generators: named in the summary without a submission number

## Most influential descendants
- K011722: Atricure Bipolar Coagulation System (2001), 92 descendants of its own
- K020919: Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 (2002), 90 descendants of its own
- K040690: Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console (2004), 42 descendants of its own
- K031247: Cardioblate Bipolar Radiofrequency Surgical Ablation System (2003), 34 descendants of its own
- K022894: Epicor Medical Ablation System (2004), 23 descendants of its own

## Indications for use
The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass (“MIDCAB”) and saphenous vein harvesting procedures.

Source page: https://510kreport.com/device/K963930
Methodology: https://510kreport.com/methodology