510(k) K211806
- Device
- Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter
- Applicant
- Venclose, Inc.
- 510(k) number
- K211806
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-03
- Date received
- 2021-06-11
- 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
- No
Applicant Contact#
- Contact
- Mai-Ly Wilcox
- Address
- 2570 N. 1st St., Floor 2, #221 San Jose CA US 95131 95131
FDA Registration Numbers#
- 3008361498
- 1221934
- 3005528784
- 3007515069
- 3002250546
- 3001592626
- 3010305275
- 9710649
- 2245304
- 1037007
- 3005110411
- 3008843439
- 9681383
- 3016099036
- 3005382983
- 1418975
- 1047843
- 3005595283
- 3013500228
- 3035374386
- 1724474
- 2182318
- 3010432890
- 3019924
- 3038675429
- 3011879048
- 3012329552
- 9611112
- 3024712917
- 3020142587
- 3005857264
- 3008816935
- 2529846
- 3007593944
- 3016813690
- 3014421917
- 3006498370
- 3007738736
- 3013421458
- 1923569
- 3011586151
- 2650143
- 3015972753
- 2649614
- 1722040
- 3043585137
- 8010312
- 9610612
- 3005350457
- 3010226575
- 3011625895
- 3007421149
- 3011230048
- 3011944170
- 3004598644
- 3007766590
- 3009599228
- 3010291427
- 3005075853
- 2030598
- 3006639944
- 3011137372
- 3013596024
- 3015231789
- 3006561161
- 1055236
- 3012757453
- 3040335671
- 3003687489
- 3007200016
- 9616696
- 3015453963
- 3004878380
- 3008998256
- 3009380063
- 1319660
- 3030447506
- 3012263546
- 3030176940
Source Documents#
Other 510(k) Records For Product Code GEI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 |
| K253777 | Ascblue (8010) | Ascblue Corporation | 2026-04-10 |