510(k) K961695
- Device
- ENDO-TECH LTD., TIPS
- Applicant
- Ratio Design Lab
- 510(k) number
- K961695
- Product code
- HFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-01
- Date received
- 1996-05-01
- Regulation
- 884.4160
- Classification name
- Coagulator, Laparoscopic, Unipolar (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIM B LUSBY
- Address
- 4040 Nine Mcfarland, Suite 800 Alpheretta GA US 30201 30201
FDA Registration Numbers#
- 1721676
- 3010280625
- 3013557562
- 1055236
- 3013247477
- 3030447506
- 3007015148
- 3006330030
- 3004491689
- 1649518
- 9610773
- 1320894
- 3002807310
- 1319639
- 3011050570
- 1222780
- 1043214
- 3004111573
- 3012494290
- 3036773433
- 2320762
- 1054241
- 9617070
Source Documents#
Other 510(k) Records For Product Code HFG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181124 | Acessa ProVu System | Acessa Health, Inc. | 2018-09-28 |
| K132744 | ACESSA GUIDANCE SYSTEM | Halt Medical, Inc. | 2014-05-27 |
| K132184 | ACESSA GUIDANCE HANDPIECE | Halt Medical, Inc. | 2014-04-28 |
| K121858 | THE ABLATION SYSTEM | Halt Medical, Inc. | 2012-11-05 |
| K101606 | MICROMED PD-8K INSULATION DEFECT DETECTOR | Mcgan Technology, LLC | 2010-10-01 |
| K991424 | INSULSCAN INSULATION TESTING SYSTEM | Medicor Corp. | 1999-07-22 |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Davol, Inc. | 1994-03-25 |
| K915406 | DAVOL ELECTROSUGICAL PROBES | Davol, Inc. | 1992-02-28 |
| K904240 | SINGLE USE LAPARSCOPIC ELECTRODE | Aspen Labs | 1991-02-19 |
| K902555 | AMCATH COAGULATION PROBE | Intl. Medical, Inc. | 1990-06-20 |