21 CFR 884.4160 — Coagulator, Laparoscopic, Unipolar (And Accessories)
Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4160
Identification
A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | 2 | 11 | 3rd Party |
| HFH | Coagulator, Hysteroscopic (And Accessories) | 2 | 0 | 3rd Party |
| HFI | Coagulator, Culdoscopic (And Accessories) | 2 | 8 | 3rd Party |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | 44 | 3rd Party |
