510(k) K962293
- Device
- ENDOSONICS AUTOMATIC PULL BACK DEVICE
- Applicant
- ENDOSONICS CORP.
- 510(k) number
- K962293
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-16
- Date received
- 1996-06-14
- 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
- ADAM D SAVAKUS
- Address
- 3078-B Prospect Park Dr. Rancho Cordova CA US 95670 95670
FDA Registration Numbers#
- 3013436538
- 3006786907
- 3011763071
- 9616515
- 3003832357
- 3003594449
- 3013058729
- 3012747207
- 3013764800
- 3016696283
- 1720929
- 3006116468
- 3006265099
- 3012081348
- 3031851875
- 3015136743
- 3010305275
- 3033275035
- 1000602763
- 1224842
- 1222780
- 9611033
- 3012387143
- 3008595936
- 1000589001
- 1018233
- 2936921
- 1060680
- 9615439
- 3017263724
- 3011106828
- 3021970996
- 3017140456
- 3012975098
- 3016842138
- 3005785090
- 3014574557
- 3014639846
- 2531814
- 3012316249
- 3014555455
- 3011396687
- 3005334138
- 3010398867
- 3004009431
- 3019216
- 3015997711
- 3017487805
- 3004752776
- 3033743848
- 2024024
- 3038718997
- 3010703925
- 3003623887
- 3012127758
- 1043214
- 3004035727
- 9710602
- 3013181568
- 3008627763
- 3014432311
- 3008640801
- 3009565060
- 3007015148
- 3011274144
- 1319660
- 3045019904
- 9615849
- 3011416394
- 3012494290
- 2020394
- 3004181533
- 3013727803
- 2011171
- 8010047
- 3043534483
- 1422634
- 2950776
- 3010193531
- 3017968993
Source Documents#
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
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