ORC Endoscopic Monopolar Electrosurgical Probe
by O.R. Concepts, Inc. 510(k)
Active
510(k) K926242
Overview
The ORC Endoscopic Monopolar Electrosurgical Probe is a monopolar electrosurgical probe designed for endoscopic surgical procedures. It delivers controlled electrical energy to tissue, facilitating precise cutting, coagulation, or desiccation during minimally invasive operations. This device is intended for use in general and plastic surgery applications, where endoscopic access is required. Its design supports integration with electrosurgical generators to ensure safe and effective tissue manipulation.
The probe is supplied as a reusable medical device, intended for use in sterile surgical environments. It is classified under FDA product code GEI and holds a FDA 510(k) clearance (K926242), granted as substantially equivalent to a predicate device. No specific MRI safety classification or single-use designation is noted in the regulatory data. Proper sterilization and maintenance protocols must be followed to ensure device integrity and patient safety. Storage should adhere to manufacturer guidelines to preserve functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926242 | Date15 Oct 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from O.R. Concepts, Inc.
Questions
What is the ORC Endoscopic Monopolar Electrosurgical Probe used for?
This device is designed for endoscopic surgical procedures, enabling controlled electrical energy delivery to tissue. It facilitates precise cutting, coagulation, or desiccation during minimally invasive operations, particularly in general and plastic surgery where endoscopic access is required. The probe integrates with electrosurgical generators to ensure safe and effective tissue manipulation.
Is the ORC Endoscopic Monopolar Electrosurgical Probe single-use or reusable?
The ORC Endoscopic Monopolar Electrosurgical Probe is intended for reuse. It is classified as a reusable medical device and must be properly sterilized and maintained between uses to ensure patient safety and device integrity. Adherence to manufacturer guidelines for sterilization and storage is critical.
What sterilization and storage protocols should be followed for this device?
Since this probe is reusable, it must undergo proper sterilization after each use to maintain its functionality and ensure patient safety. The manufacturer provides specific sterilization protocols that should be strictly followed. Storage should also adhere to these guidelines to preserve the device’s integrity and performance, preventing contamination or damage.
Does this device have any specific MRI safety classification?
The regulatory data for the ORC Endoscopic Monopolar Electrosurgical Probe does not specify an MRI safety classification. Clinicians should consult the manufacturer’s instructions for use to determine compatibility with MRI environments or procedures, as electrosurgical devices may pose risks in such settings.
What regulatory clearance does this device hold?
The ORC Endoscopic Monopolar Electrosurgical Probe holds FDA 510(k) clearance (K926242), granted as substantially equivalent to a predicate device. This clearance was issued under the FDA product code GEI, indicating its classification for general and plastic surgery applications. The device was reviewed by the Surgical Devices Panel (SU) and received traditional clearance.