510(k) K040840
- Device
- TERATECH MODEL 10V5 SMART PROBE
- Applicant
- TERATECH CORP.
- 510(k) number
- K040840
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-14
- Date received
- 2004-04-01
- 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
- Yes
Applicant Contact#
- Contact
- CHARLES F HOTTINGER
- Address
- P.O. Box 10074 13221 NE Teem Loop Rd. Bainbridge Island WA US 98110 98110
FDA Registration Numbers#
- 1422634
- 3005785090
- 3005099803
- 9611680
- 1836161
- 3005403518
- 1000269286
- 3014555455
- 3008386005
- 3027788423
- 3002183074
- 2031962
- 3013368530
- 3027501622
- 3009499478
- 3014745562
- 9613067
- 1820334
- 3007695959
- 2950776
- 3008627763
- 3006161756
- 2531475
- 3015531959
- 3007194257
- 9616086
- 3009482034
- 1000393132
- 9616774
- 2518897
- 2938651
- 9610877
- 3008496839
- 3031158
- 1055823
- 3010610157
- 1018470
- 1018233
- 3015194986
- 2939830
- 1222780
- 3010305275
- 3017884667
- 3010041511
- 3013443304
- 3009286597
- 2518586
- 2183744
- 3042585081
- 3011763071
- 3016854601
- 3042172882
- 9615439
- 3009756153
- 3013727803
- 3015972810
- 3012387143
- 3004574050
- 3008132411
- 2134812
- 3004705634
- 3042225166
- 3015972753
- 1000589001
- 3007562060
- 3023245
- 2030624
- 3012081348
- 3013181568
- 3016678045
- 3032367
- 3009196578
- 3003647374
- 3010952312
- 3007143236
- 3013041594
- 3014432311
- 2531814
- 9613994
- 3010258456
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 |
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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