Bipolar Micro-Coagulation Forceps
by Günter Bissinger Medizintechnik GmbH
510(k) K172368
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172368 | Date5 Apr 2018 | 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- Withdrawn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
- Gunter Bissinger Medizintechnik GmbH
- 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 Bipolar Micro-Coagulation Forceps is a surgical instrument classified under the General, Plastic Surgery advisory committee category, designed for bipolar electrosurgical coagulation. This device delivers precise tissue coagulation by applying controlled electrical energy through its jaws, minimizing collateral damage to surrounding tissues. Its micro design enables fine manipulation, making it suitable for delicate surgical procedures. The forceps operate using bipolar technology, which isolates the current flow to the targeted tissue, enhancing safety and efficacy during coagulation tasks.
The Bipolar Micro-Coagulation Forceps is intended for use in operating rooms by trained surgical personnel. Constructed from surgical steel, it is reusable and requires proper cleaning, sterilization, and maintenance per manufacturer guidelines. The device is FDA-cleared under the 510(k) Traditional pathway, with a clearance number K172368. It is not labeled for MRI compatibility or single-use applications. Storage should follow standard surgical instrument protocols to preserve functionality and sterility.
Other devices from Günter Bissinger Medizintechnik GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the Bipolar Micro-Coagulation Forceps used for?
The Bipolar Micro-Coagulation Forceps is designed for bipolar electrosurgical coagulation during surgical procedures. It delivers controlled electrical energy through its jaws to precisely coagulate tissue, minimizing damage to surrounding areas. This makes it ideal for delicate operations in plastic surgery and other fields requiring fine tissue control.
How is the Bipolar Micro-Coagulation Forceps supplied and maintained?
The forceps are supplied as a reusable surgical instrument made from surgical steel. After each use, they must be thoroughly cleaned, sterilized, and maintained according to the manufacturer’s guidelines to ensure proper functionality and longevity. Proper care extends the device’s lifespan and preserves its performance for repeated surgical applications.
Is the Bipolar Micro-Coagulation Forceps single-use or reusable?
The Bipolar Micro-Coagulation Forceps is explicitly designed for reuse. It is not intended for single-use applications and must undergo cleaning, sterilization, and maintenance between procedures to maintain safety and efficacy. Reusability aligns with standard operating room practices for durable surgical instruments.
What storage guidelines should be followed for this device?
Storage should adhere to standard protocols for surgical instruments to preserve functionality and sterility. The forceps should be kept in a clean, dry environment, protected from moisture, sharp objects, or excessive pressure that could damage the jaws or electrical components. Proper storage ensures the device remains ready for use when needed.
Can the Bipolar Micro-Coagulation Forceps be used in MRI environments?
The device is not labeled for MRI compatibility, meaning it should not be used in magnetic resonance imaging environments. This restriction applies to both the forceps themselves and any associated accessories or packaging. Always verify compatibility with the specific MRI system before use.