510(k) K171040
- Device
- Reusable Guides Ranges (PERINE Range, NAIL Range, CON-LEAD Range And LIN-LEAD Range) And STEADY PRO Range
- Applicant
- Koelis
- 510(k) number
- K171040
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-31
- Date received
- 2017-04-06
- Regulation
- 892.1570
- Classification name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laetitia GERVAIS
- Address
- 16, Chemin Du Vieux Chene Meylan FR 38240 38240
FDA Registration Numbers#
- 1000601180
- 2029275
- 3016096098
- 3004181533
- 3010280625
- 3019216
- 3043011436
- 3003925093
- 2020394
- 1836161
- 3012761544
- 3012747207
- 3025786376
- 3003971136
- 9610595
- 3006441164
- 3004574050
- 3006265099
- 8030607
- 3015972810
- 3043012240
- 3011692238
- 3013944123
- 3003832357
- 3016854601
- 3010703925
- 2024024
- 3007562060
- 1000393132
- 2124215
- 3008496839
- 3009286597
- 3031851875
- 3007994837
- 3010220244
- 3003637092
- 3010193531
- 3010258456
- 9611125
- 3008177921
- 3011416394
- 2521877
- 3014639846
- 3013436538
- 3008640801
- 3016493665
- 3032109181
- 9611033
- 1045254
- 3013557562
- 3013595964
- 3004530184
- 2434141
- 3014302721
- 3011688715
- 3013727803
- 2183744
- 3034286426
- 3009490946
- 3009436116
- 3014605202
- 3010060157
- 3008487708
- 9611665
- 3004009431
- 9610482
- 3045019904
- 3008515880
- 1216677
- 3009499478
- 3021970996
- 1126271
- 3042225166
- 1018470
- 3004752776
- 3015525240
- 3005785090
- 3014769442
- 3014421917
- 3005877899
Source Documents#
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261170 | BA-004CC | Fujifilm Corporation | 2026-08-12 |
| K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | 2026-08-10 |
| K260161 | SmartGuide Disposable Guides and Grids | UC-CARE , Ltd. | 2026-07-30 |
| K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026-07-27 |
| K261014 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2026-07-24 |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | 2025-09-18 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | 2025-07-11 |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | 2025-07-02 |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2025-06-13 |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024-08-30 |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024-08-15 |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024-07-03 |
| K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | 2023-12-22 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | 2023-12-13 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
Legacy Summary#
summary
FDA Review#
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