# K981361: Powerstar Bipolar Scissors

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 13, 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.
136 later devices descend from it; 5 cite it directly.
0 of 137 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) PowerStar Bipolar Scissors: named in the summary without a submission number

## Most influential descendants
- K014290: Entec Plasma Wands (2002), 119 descendants of its own
- K021364: Modification to Entec Plasma Wands (2002), 94 descendants of its own
- K030108: Arthrocare Ent Coblator Surgery System (2003), 92 descendants of its own
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes) (2002), 76 descendants of its own
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own

## Indications for use
The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries. Surgical procedures would include, among others, the following: General Surgery Bowel Breast Biopsies Hernia Repair Lysis of Adhesions Upper GI GI (other) Cholecystectomy Thyroid Splenectomy OB/GYN Surgery Hysterectomy Salpingo-oophrectomy Myomectomy Endometriosis Ovariohysterectomy Ear, Nose & Throat Surgery Neck Mass Mastoidectomy Tympanoplasty Tonsillectomy Oncologic Mastectomy Axillary Node Dissection Plastic Surgery Mammoplasty Blepharoplasty Rhytidectomy Panniculectomy Forearm Pedicle Flap Urological Surgery Nephrectomy Prostatectomy Cystotomy Cardiovascular/Thoracic Surgery Femoral Popliteal Bypass Internal Mammary Artery (IMA) Harvesting Pericardial Window Biopsy of the Thymus

Source page: https://510kreport.com/device/K981361
Methodology: https://510kreport.com/methodology