510(k) K180970
- Device
- Disposable Guides KDNG00
- Applicant
- Koelis
- 510(k) number
- K180970
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-07-10
- Date received
- 2018-04-13
- 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
- Pauline Nicole
- Address
- 16, Chemin Du Vieux Chene Meylan FR 38240 38240
FDA Registration Numbers#
- 3009286597
- 3003594449
- 3003681187
- 3004009431
- 3008640801
- 9614641
- 2031044
- 1319639
- 3008321254
- 3035373446
- 3010280625
- 2518586
- 3005785090
- 3033743848
- 2936921
- 1216677
- 3005875675
- 1000602763
- 3010703925
- 3007544634
- 3011274144
- 3009436116
- 3003851073
- 3012316249
- 3026405201
- 8030607
- 3007699067
- 3008515880
- 3013462478
- 3043012240
- 2133810
- 9617592
- 3015525240
- 3006850123
- 3015972810
- 9710090
- 3013181568
- 3019784575
- 3016171942
- 9680269
- 1126271
- 1225687
- 3003600763
- 3003925093
- 3008363989
- 3007603826
- 2950776
- 1066427
- 3034286426
- 3002808148
- 3034232408
- 3013595964
- 3012811961
- 1061927
- 3006382185
- 3012387143
- 3003995932
- 3003782610
- 3016076141
- 3010041511
- 2183744
- 9617277
- 3023245
- 3042225166
- 3006082230
- 3043534483
- 3010663777
- 3011137372
- 3010760216
- 3017140456
- 3017057763
- 3007015148
- 3006161756
- 3009756153
- 3016696283
- 2134812
- 3007738736
- 3017233611
- 3013764800
Source Documents#
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026-09-24 |
| 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 |
Legacy Summary#
summary
FDA Review#
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