510(k) K001270
- Device
- GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
- Applicant
- GYRUS MEDICAL LTD.
- 510(k) number
- K001270
- Product code
- FJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-04-28
- Date received
- 2000-04-20
- Regulation
- 876.1500
- Classification name
- Resectoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID KAY
- Address
- Fortran Rd., St. Mellons Cardiff, Wales GB CF3 0LT CF3 0LT
FDA Registration Numbers#
- 3006546082
- 3013247477
- 3028977843
- 2431166
- 9610617
- 3007960282
- 3010202439
- 1649518
- 3009746061
- 9611102
- 2020550
- 9610773
- 3002807310
- 2243757
- 1000548922
- 9610614
- 3011050570
- 3014342096
- 9680515
- 3012322232
- 3013031133
- 1057358
- 3004784537
- 3004111573
- 3013011598
- 1418479
- 8010418
- 9614969
- 2424366
- 3009217531
- 3024021261
- 3037966040
- 3031240334
- 3010707607
- 3015895045
- 9617070
- 2953359
- 2183744
- 2085947
Source Documents#
Other 510(k) Records For Product Code FJL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG | 2024-05-07 |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | 2023-03-17 |
| K230205 | Veloxion System | Corinth Medtech, Inc. | 2023-02-24 |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | 2019-06-13 |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch | Corinth Medtech, Inc. | 2019-03-15 |
| K162979 | Veloxion System | Corinth Medtech, Inc. | 2017-03-24 |
| K102663 | AED RESECTOSCOPE | National Advanced Endoscopy Devices, Inc. | 2010-12-30 |
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | Richard Wolf Medical Instruments Corp. | 2007-03-22 |
| K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES | Richard Wolf Medical Instruments Corp. | 2005-03-18 |
| K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 | Richard Wolf Medical Instruments Corp. | 2004-08-19 |
| K971881 | COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS | Comeg Endoscopy | 1997-08-12 |
| K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | Gynecare Innovation Center | 1997-02-04 |
| K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | Gynecare Innovation Center | 1996-09-16 |
| K960757 | KARL STORZ URETER RESECTOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1996-05-01 |
| K954050 | RESECTOSCOPES | KARL STORZ Endoscopy-America, Inc. | 1995-11-22 |
Legacy Summary#
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FDA Review#
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