510(k) K001203
- Device
- OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
- Applicant
- THE OLYMPUS OPTICAL CO.
- 510(k) number
- K001203
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-05-26
- Date received
- 2000-04-13
- 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
- LAURA STORMS-TYLER
- Address
- Two Corporate Dr. Melville NY US 11747 11747
FDA Registration Numbers#
- 3005406110
- 3007143236
- 1062741
- 3008487708
- 3008729547
- 2518897
- 3004181533
- 3003589956
- 3017955833
- 2531475
- 3010663777
- 9617592
- 2521877
- 3009435759
- 3010390468
- 3026047529
- 3002808148
- 3043226252
- 3009156722
- 3027501622
- 3006786907
- 3010400367
- 3004727093
- 3011692238
- 9615439
- 9610877
- 3012198618
- 3007740628
- 3008548323
- 3011162972
- 3011050570
- 3003971136
- 3013844297
- 3011392709
- 3015194986
- 3003647374
- 8020021
- 3007015148
- 3007994837
- 3007603826
- 3025786376
- 3008223664
- 3035950510
- 3010760216
- 3010082909
- 3014809646
- 3009077524
- 3011416394
- 3026405201
- 1225687
- 3009482034
- 3007562060
- 2030624
- 3031259044
- 3010933511
- 1037885
- 1043214
- 3004574050
- 3031823165
- 2031044
- 3006597338
- 2522950
- 1226587
- 3035373446
- 1047843
- 3042585081
- 1000393132
- 9680135
- 3012387143
- 3029916061
- 1126271
- 3008627763
- 3040391009
- 3005877899
- 3009758186
- 3010389834
- 3006110251
- 2029275
- 3011106828
Source Documents#
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026-09-24 |
| K261170 | BA-004CC | Fujifilm Corporation | 2026-08-12 |
| K254143 | EM-TECH Passive Ultrasound Probe Strap | EM-TECH Solutions, Inc. | 2026-08-10 |
| 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 |
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