Symbiosis Bipolar Forceps
510(k) K952432
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952432 | Date5 Jul 1995 | 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- Withdrawn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
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Symbiosis Bipolar Forceps is a surgical instrument designed for bipolar electrosurgical procedures. It is used to grasp tissue and deliver bipolar electrical current for coagulation and hemostasis during surgical interventions.
The device is supplied by Symbiosis Corp. and is intended for use in general and plastic surgery settings. It is a single-use, sterile device that is not MRI safe. The product is regulated under FDA class 2 and was cleared through the 510(k) premarket notification process under K952432.
Other devices from Symbiosis Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the Symbiosis Bipolar Forceps used for?
It is a surgical instrument used to grasp tissue and deliver bipolar electrical current for coagulation and hemostasis during surgical interventions in general and plastic surgery settings.
How is the device supplied and is it sterile?
The Symbiosis Bipolar Forceps is supplied by Symbiosis Corp. as a single-use, sterile device, meaning it is intended for one patient use only and comes pre-sterilized for immediate clinical use.
Is this device MRI safe?
No, the Symbiosis Bipolar Forceps is not MRI safe and should not be used in or near magnetic resonance imaging environments due to potential risks from magnetic fields.
What is the regulatory status and clearance pathway?
The device is regulated under FDA class 2 and was cleared through the 510(k) premarket notification process under K952432, with a decision of substantially equivalent made on July 5, 1995.
What surgical specialties is it intended for?
The device is intended for use in general and plastic surgery settings, as indicated by its advisory committee classification and clinical application in tissue grasping and hemostasis.