HFG — Coagulator, Laparoscopic, Unipolar (And Accessories) Class II
FDA product code HFG covers "Coagulator, Laparoscopic, Unipolar (And Accessories)", a Class II medical device regulated under 21 CFR 884.4160. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HFG
- Device Class
- Class II
- Regulation Number
- 884.4160
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181124 | acessa health | Acessa ProVu System | September 28, 2018 |
| K132744 | halt medical | ACESSA GUIDANCE SYSTEM | May 27, 2014 |
| K132184 | halt medical | ACESSA GUIDANCE HANDPIECE | April 28, 2014 |
| K121858 | halt medical | THE ABLATION SYSTEM | November 5, 2012 |
| K101606 | mcgan technology | MICROMED PD-8K INSULATION DEFECT DETECTOR | October 1, 2010 |
| K991424 | medicor | INSULSCAN INSULATION TESTING SYSTEM | July 22, 1999 |
| K961695 | ratio design lab | ENDO-TECH LTD., TIPS | July 1, 1996 |
| K921405 | davol | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | March 25, 1994 |
| K915406 | davol | DAVOL ELECTROSUGICAL PROBES | February 28, 1992 |
| K904240 | aspen labs | SINGLE USE LAPARSCOPIC ELECTRODE | February 19, 1991 |
| K902555 | intl. medical | AMCATH COAGULATION PROBE | June 20, 1990 |