HFI · Coagulator, Culdoscopic (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4160 · Class 2
Overview
| Product Code | HFI |
|---|---|
| Device Name | Coagulator, Culdoscopic (And Accessories) |
| Regulation | 21 CFR 884.4160 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151567 | ENDOPLUS hand-held laparoscopic instruments | Endoplus | Dec 23, 2015 | SESE |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | Jun 7, 1994 | SESE |
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | Jun 7, 1994 | SESE |
| K936026 | COOK LAPAROSCOPIC MINI RETRACTOR SET | Cook Urological, Inc. | Mar 11, 1994 | SESE |
| K925114 | LAPAROSCOPIC INSTRUMENTS | Endo Technic Corp. | Feb 28, 1994 | SESE |
| K924148 | DIAMOND-SHARP(R) TROCARS | Snowden-Pencer | Feb 28, 1994 | SESE |
| K930571 | REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING | Numed Technologies, Inc. | Feb 1, 1994 | SESE |
| K844053 | CANON 60 DEGREE FUNDUS CAMERA CF-60S | Canon USA, Inc. | Dec 19, 1984 | SESE |
Top Applicants
- Zinnanti Surgical Instruments, Inc. — 2 clearances
- Canon USA, Inc. — 1 clearance
- Cook Urological, Inc. — 1 clearance
- Endo Technic Corp. — 1 clearance
- Endoplus — 1 clearance
