Electrode, Flexible Suction Coagulator
The Flexible Suction Coagulator Electrode (product code FEH) is an electrosurgical accessory combining suction and coagulation functions in a flexible electrode form, used to simultaneously evacuate fluids and achieve hemostasis during endoscopic or open gastrointestinal or urological procedures. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.4300 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FEH
- Device Class
- FDA class 2
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K130489 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | Apr 19, 2013 | Substantially Equivalent | Optim, LLC |
| K122593 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | Sep 13, 2012 | Substantially Equivalent | Optim, LLC |
| K803214 | ACMI BIPOLAR HEMOSTATIC ELECTRODE | Jan 15, 1981 | Substantially Equivalent | American Cystocope Makers, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.