510(k) K251403
- Device
- Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )
- Applicant
- Dornier Medtech America Inc (Dmta)
- 510(k) number
- K251403
- Product code
- FAS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-05
- Date received
- 2025-05-06
- Regulation
- 876.4300
- Classification name
- Electrode, Electrosurgical, Active, Urological
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- John Hoffer
- Address
- 1155 Roberts Blvd., Suite 100 Kennesaw GA US 30144 30144
FDA Registration Numbers
- 3014769442
- 3024021261
- 3014615697
- 1037955
- 1651252
- 2183744
- 9611102
- 3006546082
- 3013247477
- 3010399422
- 3004361445
- 9680515
- 3012460907
- 3013011598
- 3012322232
- 9617070
- 1418479
- 2243757
- 3003780911
- 3005580113
- 9614969
- 2244478
- 9610614
- 3004215117
- 3002807310
- 1054811
- 3003790304
- 9610773
- 1422634
- 3009217531
- 9611503
- 9611590
- 2431166
- 3042471321
- 2085947
- 3031240334
- 3004111573
- 3008040402
- 2424366
- 8010877
- 3010707607
- 9614641
- 8010047
- 3011050570
- 3008132398
- 9610617
- 3011987935
- 3010202439
- 2936485
- 9680718
- 1649518
- 2020550
- 3004784537
- 3015895045
- 3014342096
- 3006082230
- 3008837339
- 3007960282
- 3011586151
- 1018233
- 8010418
- 3011989678
- 1057358
- 3009420598
- 3010383847
Source Documents
Other 510(k) Records For Product Code FAS
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|---|---|---|---|
| K250522 | Multi4 System | Multi4 Medical AB | 2025-06-27 |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | 2024-06-12 |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | Chirurgie Innovation | 2022-03-02 |
| K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2021-08-03 |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | 2021-05-19 |
| K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017-09-28 |
| K163090 | Plasma Edge System | Chirurgie Innovation | 2017-05-23 |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Omnitech Systems, Inc. | 2016-06-27 |
| K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015-10-26 |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | Olympus Winter & Ibe GmbH | 2012-06-20 |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2012-06-20 |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS | Olympus Winter & Ibe GmbH | 2011-01-11 |
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | Olympus Winter & Ibe GmbH | 2010-07-01 |
| K093181 | GYRUS ACMI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | 2010-02-24 |
| K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES | Modern Medical Equipment Mfg., Ltd. | 2010-01-15 |