Coagulator, Laparoscopic, Unipolar (And Accessories)
The Laparoscopic Unipolar Coagulator (and accessories) is a surgical instrument used during laparoscopic procedures to apply unipolar electrosurgical current to tissues for hemostasis or tissue destruction, including in procedures such as laparoscopic sterilization. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFG, regulated under 21 CFR 884.4160, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HFG
- Device Class
- FDA class 2
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K181124 | Acessa ProVu System | Sep 28, 2018 | Substantially Equivalent | Acessa Health, Inc. |
| K132744 | ACESSA GUIDANCE SYSTEM | May 27, 2014 | Substantially Equivalent | Halt Medical, Inc. |
| K132184 | ACESSA GUIDANCE HANDPIECE | Apr 28, 2014 | Substantially Equivalent | Halt Medical, Inc. |
| K121858 | THE ABLATION SYSTEM | Nov 05, 2012 | Substantially Equivalent | Halt Medical, Inc. |
| K101606 | MICROMED PD-8K INSULATION DEFECT DETECTOR | Oct 01, 2010 | Substantially Equivalent | Mcgan Technology, LLC |
| K991424 | INSULSCAN INSULATION TESTING SYSTEM | Jul 22, 1999 | Substantially Equivalent | Medicor Corp. |
| K961695 | ENDO-TECH LTD., TIPS | Jul 01, 1996 | Substantially Equivalent | Ratio Design Lab |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Mar 25, 1994 | Substantially Equivalent | Davol, Inc. |
| K915406 | DAVOL ELECTROSUGICAL PROBES | Feb 28, 1992 | Substantially Equivalent | Davol, Inc. |
| K904240 | SINGLE USE LAPARSCOPIC ELECTRODE | Feb 19, 1991 | Substantially Equivalent | Aspen Labs |
| K902555 | AMCATH COAGULATION PROBE | Jun 20, 1990 | Substantially Equivalent | Intl. Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.