510(k) K973958
- Device
- GENERAL PURPOSE ATL NEEDLE GUIDE KIT
- Applicant
- PROTEK MEDICAL PRODUCTS, INC.
- 510(k) number
- K973958
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-01-22
- Date received
- 1997-10-16
- Regulation
- 892.1570
- Classification name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICK L PRUTER
- Address
- 221 E. Market St. Suite 291 Iowa City IA US 52245 52245
FDA Registration Numbers#
- 3014279513
- 1937397
- 3002619337
- 3013368530
- 3013462478
- 8043933
- 3015806723
- 3024838922
- 3005860720
- 3017968993
- 3033743848
- 2936921
- 3015997711
- 3016076141
- 3031158
- 9710090
- 8010047
- 3016854601
- 3009247326
- 3003995932
- 3017944270
- 3015499445
- 9680135
- 3017057763
- 2020394
- 3003774756
- 3045019904
- 1055823
- 3015276088
- 3010188783
- 3003681187
- 2433682
- 3008627763
- 3004009431
- 1054713
- 3008950127
- 9611680
- 3008386005
- 3012127758
- 2950776
- 1060680
- 3010082909
- 3015972810
- 3043226252
- 3006979678
- 3038718997
- 1018233
- 3010432890
- 3003971136
- 2518897
- 3016842138
- 3011274144
- 3008548323
- 3037874486
- 2134812
- 2124215
- 3009436116
- 3008640801
- 2522950
- 3004987887
- 1062741
- 1650907
- 9610595
- 3006110251
- 3017636737
- 3013181568
- 1319660
- 8020021
- 3003925093
- 3005875675
- 1216677
- 3012494290
- 3015136743
- 2031962
- 3043534483
- 3014605202
- 1000589001
- 1048735
- 3003647374
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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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