510(k) K231666
- Device
- Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
- Applicant
- FUJIFILM Healthcare Americas Corporation
- 510(k) number
- K231666
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-13
- Date received
- 2023-06-07
- 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
- Chaitrali Kulkarni
- Address
- 81 Hartwell Ave. Suite 300 Lexington MA US 02421 02421
FDA Registration Numbers#
- 3033527241
- 1222780
- 3010258456
- 1000314502
- 1221485
- 3017233611
- 3003774756
- 3013058729
- 3014605202
- 3006441164
- 3004485675
- 3013844297
- 3015525240
- 3042225166
- 1066270
- 3011688715
- 3011416394
- 3010827261
- 3014574557
- 3015997711
- 3010400367
- 3012387143
- 1047843
- 3010102386
- 3009196578
- 3006161756
- 3012811961
- 3013041594
- 1225687
- 3027788423
- 3005403518
- 9611665
- 1220477
- 9610482
- 3015276088
- 3010273872
- 3008321254
- 3013429557
- 9616086
- 3005406110
- 3008386005
- 1055823
- 9611031
- 3042172882
- 3002619337
- 3002315840
- 1820334
- 3024673
- 3013515803
- 3014769442
- 3010952312
- 1226587
- 3030733800
- 3015194986
- 3003971136
- 3012104670
- 3011200896
- 3010381606
- 2938651
- 3006786907
- 3004727093
- 9611680
- 1528319
- 3032109181
- 3000126629
- 3010280625
- 2183319
- 3032109225
- 1054713
- 1037885
- 3010060157
- 3013462478
- 3008515880
- 3009529630
- 3005860720
- 2032350
- 3012747207
- 3001763079
- 3014432311
Source Documents#
Other 510(k) Records For Product Code ITX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | 2023-08-02 |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | 2023-05-12 |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023-01-11 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | 2022-06-07 |
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | 2021-09-13 |