PowerStar Bipolar Scissors
510(k) K973173
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973173 | Date29 Oct 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- FDA applicant
- ETHICON, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The PowerStar Bipolar Scissors are classified as a bipolar electrosurgical scissor (Product Code: GEI), designed for cutting and coagulating soft tissue during open surgical procedures. This device combines precision cutting with controlled bipolar coagulation to minimise bleeding and reduce thermal spread, supporting procedures in general and plastic surgery. Its design integrates electrosurgical functionality directly into the scissor mechanism, enabling simultaneous tissue division and coagulation in a single instrument.
These scissors are reusable, non-sterile devices intended for use in controlled surgical environments. They are regulated under FDA 510(k) clearance (K973173) as substantially equivalent to predicate devices, adhering to traditional review pathways. Supplied in a non-sterile state, they require sterilisation prior to use, typically via autoclave or other validated methods, and must be maintained according to manufacturer guidelines. No MRI safety information is specified, and sizing is not detailed in the provided data.
Other devices from Ethicon Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the PowerStar Bipolar Scissors designed for?
The PowerStar Bipolar Scissors are specifically engineered for cutting and coagulating soft tissue during open surgical procedures. By integrating bipolar electrosurgical functionality into the scissor mechanism, they enable simultaneous tissue division and controlled coagulation, which helps minimise bleeding and reduce thermal spread. This dual functionality supports procedures in general and plastic surgery, where precision and haemostasis are critical.
Are the PowerStar Bipolar Scissors single-use or reusable?
The PowerStar Bipolar Scissors are reusable devices. They are supplied in a non-sterile state and must be sterilised prior to use using methods like autoclaving or other validated techniques. Sterilisation and maintenance must follow the manufacturer’s guidelines to ensure safety and performance.
What surgical specialties benefit most from using these scissors?
These scissors are particularly useful in general and plastic surgery, where precise tissue manipulation and haemostasis are essential. The combination of cutting and coagulation in a single instrument reduces operative time and improves surgical control, making them ideal for procedures requiring both functions.
How should the PowerStar Bipolar Scissors be stored?
Since these scissors are reusable and non-sterile in their supplied state, they must be stored in a clean, dry environment to prevent contamination. After sterilisation for use, they should be stored in a way that maintains their sharpness and functionality, adhering to the manufacturer’s recommendations for long-term care.
Are there any specific safety considerations for using these scissors?
The PowerStar Bipolar Scissors are designed for controlled surgical environments and require proper sterilisation before use. While they are intended to minimise thermal spread, clinicians should follow standard electrosurgical safety protocols to avoid unintended tissue damage or burns. Additionally, there is no specified MRI safety information, so they should not be used in MRI-compatible procedures without verification.