510(k) K111887
- Device
- CLOSUREFAST RADIOFREQUENCY CATHETER
- Applicant
- COVIDIEN
- 510(k) number
- K111887
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-09-09
- Date received
- 2011-07-01
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Daniel Campion
- Address
- 15 Hampshire St. Mansfield MA US 02048 02048
FDA Registration Numbers#
- 3012453745
- 3015231789
- 3033511105
- 3005099803
- 3028977843
- 9710524
- 3011277660
- 3002808022
- 3005173255
- 3008132398
- 3015471899
- 3010226575
- 3013734919
- 1048735
- 3027669735
- 3006142527
- 2648666
- 3008929787
- 1047843
- 3008864603
- 3009881188
- 3015460875
- 3013298431
- 3016245399
- 3003418325
- 1721504
- 1650907
- 3009217531
- 3016746323
- 3013917867
- 2424366
- 3038675429
- 3015972753
- 3009746061
- 3014342096
- 1319639
- 3030153385
- 3012639025
- 3014262693
- 3009206941
- 3009486890
- 3006498370
- 3015241782
- 3007137643
- 8043398
- 3011120183
- 3003724334
- 3003767927
- 3006546082
- 3014769442
- 3033524168
- 3011706110
- 3009380063
- 3014980461
- 3006716777
- 9680660
- 3010653929
- 3005677568
- 2183715
- 1723170
- 9610614
- 3007014520
- 3013440400
- 3013466775
- 1526611
- 2087572
- 3015506965
- 3016248634
- 2184009
- 9680515
- 3008264458
- 3008361498
- 3013069546
- 3011221476
- 3020704423
- 3008791915
- 3007048256
- 3012510750
- 1287329
Source Documents#
Other 510(k) Records For Product Code GEI #
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| 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#
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