510(k) K070101
- Device
- UNIBLATE ELECTROSURGICAL DEVICE
- Applicant
- RITA MEDICAL SYSTEMS, INC.
- 510(k) number
- K070101
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-14
- Date received
- 2007-01-10
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- KAM H LEUNG
- Address
- 46421 Landing Pkwy. Femont CA US 94538 94538
FDA Registration Numbers#
- 3033844600
- 3044464950
- 3007499195
- 3012453745
- 3013686892
- 3016099036
- 3004911384
- 2084346
- 3042940623
- 2320762
- 3009206941
- 3009763019
- 3013421458
- 3015506965
- 3007048256
- 1066427
- 2020394
- 9681260
- 3003935342
- 3014615697
- 3007047889
- 3010701628
- 3011063460
- 3010653929
- 3009732568
- 3013783488
- 3007589150
- 3001003398
- 9710582
- 3010356635
- 9616088
- 2435119
- 2518897
- 3008805497
- 3042953831
- 3010353867
- 3011782009
- 3027267119
- 3013596024
- 3009183442
- 3013602304
- 3040335671
- 3006985163
- 1017294
- 3015433394
- 3030626857
- 1649518
- 3009903460
- 3010131466
- 3033589330
- 3002808148
- 3045816907
- 1222993
- 3012606445
- 3035482729
- 8010273
- 9610612
- 9614434
- 2032098
- 3012263546
- 3010621964
- 3005173255
- 3033536319
- 3006546082
- 3014891416
- 3007007790
- 3021192541
- 3015449142
- 1030451
- 2648623
- 3030230686
- 3023706404
- 2245574
- 3020623326
- 2183613
- 3010305275
- 3010157088
- 3007616088
- 3002579136
Source Documents#
Other 510(k) Records For Product Code GEI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 |
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | 2026-07-01 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026-06-18 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | 2026-05-29 |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases