510(k) K972152
- Device
- DEVMED STEPPING AND STABILIZING SYSTEM
- Applicant
- DEVMED CORP.
- 510(k) number
- K972152
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-15
- Date received
- 1997-06-09
- 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
- GREG WIITA
- Address
- 2655 N. Ocean Dr. Singer Island FL US 33404 33404
FDA Registration Numbers#
- 3006265099
- 3013757696
- 3010305275
- 3009436116
- 3012198618
- 3008595936
- 3008921662
- 3037874486
- 1047843
- 3013368530
- 3010432890
- 3011763071
- 2032350
- 3003774756
- 2521877
- 1000513161
- 3011692238
- 3014421917
- 3006441164
- 3007738736
- 3004752776
- 3012081348
- 3015972753
- 9614698
- 3010193531
- 3011688715
- 8041160
- 3009758186
- 3009435759
- 3007994837
- 3031259044
- 3022472
- 9611033
- 3017406171
- 3011648943
- 3011137372
- 3044744649
- 3006330030
- 9710602
- 3033858858
- 1319660
- 3043012240
- 2434141
- 3004987887
- 3002808148
- 9613067
- 1937397
- 3002183074
- 3010060157
- 3006110251
- 3014755924
- 3003925093
- 3012747207
- 1018233
- 3010102386
- 9616086
- 3045019904
- 3026405201
- 3012975098
- 1319639
- 3011200896
- 3004035727
- 3006540052
- 3017944270
- 3016493665
- 3033527241
- 3013462478
- 9615439
- 3010390468
- 2011171
- 2183319
- 3017955833
- 3038718997
- 2531814
- 3019216
- 3030733800
- 9680135
- 2518897
- 1417592
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases