Coagulating Cannula Device
by Dorsal Orthopedic Corp. 510(k)
Active
510(k) K953696
Overview
The Coagulating Cannula Device is a surgical instrument classified as a coagulating cannula under the FDA’s General, Plastic Surgery category (Product Code: GEI). It is designed to facilitate localized tissue coagulation during surgical procedures, enabling precise control of bleeding by applying electrocautery at the distal end of the cannula. The device combines a nonconductive cylindrical shaft with a nonconductive hub, allowing for targeted coagulation without the need for additional motorized instruments. Its primary function is to reduce bleeding in localized areas while minimizing tissue trauma.
This device is supplied as a reusable medical instrument, as indicated by its FDA 510(k) clearance (K953696) under Traditional review, granted in 1995. It is intended for use in surgical settings where controlled coagulation is required, such as in plastic surgery or related procedures. The cannula’s design ensures compatibility with standard surgical equipment and adheres to regulatory standards for electrocautery devices. No specific sterility or single-use designation is stated in the available data, though typical surgical practice would require proper sterilization between uses.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953696 | Date8 Dec 1995 | 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- Withdrawn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
Questions
What is the primary purpose of the Coagulating Cannula Device?
The Coagulating Cannula Device is designed to facilitate localized tissue coagulation during surgical procedures. By applying electrocautery at its distal end, it provides precise control over bleeding in specific areas while minimizing tissue trauma. This makes it particularly useful in surgical settings where bleeding must be managed carefully, such as in plastic surgery or related procedures.
Is the Coagulating Cannula Device single-use or reusable?
The Coagulating Cannula Device is classified as a reusable medical instrument, as confirmed by its FDA 510(k) clearance (K953696). While the data does not explicitly state sterility requirements, reusable surgical instruments like this typically require proper sterilization between uses to ensure safety and prevent infection. Always follow established surgical sterilization protocols.
How does the design of the Coagulating Cannula Device differ from other coagulating tools?
Unlike motorized coagulating tools, the Coagulating Cannula Device combines a nonconductive cylindrical shaft and a nonconductive hub, allowing for targeted coagulation without additional equipment. Its design ensures compatibility with standard surgical tools while delivering precise electrocautery at the distal end, making it ideal for localized bleeding control in procedures like plastic surgery.
What type of surgical procedures is this device intended for?
The Coagulating Cannula Device is intended for surgical settings where controlled coagulation is required. Its primary applications include plastic surgery and related procedures where precise bleeding management is essential. The device’s design ensures it can be used effectively in these specialized environments while adhering to regulatory standards for electrocautery tools.
What regulatory pathway was followed for this device’s clearance?
The Coagulating Cannula Device received FDA 510(k) clearance (K953696) under Traditional review in 1995. The clearance was granted as substantially equivalent to a predicate device, with the submission reviewed by the Surgical and Urological Devices (SU) Advisory Committee. This pathway confirms its compliance with FDA standards for coagulating cannulas in the General, Plastic Surgery category.