Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Force…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130669 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a bipolar and monopolar electrosurgical forceps designed for grasping, manipulating, cutting, and coagulating soft tissue during surgical procedures. These forceps deliver controlled electrosurgical energy to achieve precise tissue effects, with separate configurations for monopolar and bipolar applications. The bipolar variant isolates current flow to a targeted area, while the monopolar variant relies on a grounding pad for current return. Both are intended for use in general and plastic surgery settings where electrosurgical functionality is required.
These forceps are available in both single-use and multi-use variants, allowing for flexibility in surgical workflows. The single-use models are sterile, disposable, and intended for one-time use to reduce infection risk, while the multi-use versions are reusable with appropriate cleaning and sterilization. The devices are classified under FDA product code GEI and hold a 510(k) clearance (K130669) for substantial equivalence. No specific MRI safety or size variations are noted in the regulatory data.
Frequently asked questions
What are these forceps used for in surgery?
These forceps are designed for grasping, manipulating, cutting, and coagulating soft tissue during surgical procedures. The bipolar variant isolates current flow to a targeted area, reducing collateral damage, while the monopolar variant requires a grounding pad for current return. They are specifically intended for use in general and plastic surgery settings where controlled electrosurgical energy is required.
How do I know if I should use the single-use or multi-use version?
The choice depends on your workflow and infection control needs. Single-use forceps are sterile, disposable, and intended for one-time use to minimize infection risk. Multi-use versions are reusable but require proper cleaning and sterilization between procedures. Single-use models are ideal for reducing cross-contamination, while multi-use models offer cost savings for high-volume settings where sterilization protocols are strictly followed.
Are these forceps sterile when received?
Yes, the single-use models are sterile and packaged for one-time use. The multi-use versions are not sterile upon receipt and must be cleaned, inspected, and sterilized before first use. Always follow manufacturer guidelines for sterilization to ensure safety and functionality.
Can these forceps be reused if purchased as single-use?
No, single-use forceps are designed for one-time use only. Reusing them violates sterility standards and increases infection risks. Multi-use models are explicitly intended for reprocessing and reuse with proper cleaning and sterilization procedures. Never reuse single-use devices unless explicitly approved by the manufacturer.
What regulatory approvals do these forceps hold?
These forceps hold FDA 510(k) clearance (K130669) under product code GEI, demonstrating substantial equivalence to a predicate device. The clearance covers both bipolar and monopolar configurations in single-use and multi-use variants for use in general and plastic surgery. Always verify the specific model’s approval status with the manufacturer or regulatory records.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use ..., K130669 FDA 510 (k) - SINGLE USE & MULTI USE BIPOLAR FORCEPS ..., Olsen® Precision Non-Stick Bipolar Forcep, Single-use, Non-Irrigating ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130669 | Class II | Active |
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Manufacturer
- Manufacturer
- Olsen Medical
Sources (1)
- FDA 510(k) K130669 24 fields · synced Oct 5, 2026