510(k) K213087
- Device
- Natural Rubber Latex Ultrasound Transducer Probe Covers
- Applicant
- Global Protection Corp.
- 510(k) number
- K213087
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-07
- Date received
- 2021-09-24
- 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
- Christina Cataldo
- Address
- 12 Channel St. Boston MA US 02210 02210
FDA Registration Numbers#
- 3013844297
- 3013557562
- 3007015148
- 1060680
- 3009286597
- 3010663777
- 9710018
- 3032367
- 3045030482
- 3017955833
- 3016842138
- 3008729547
- 3012038665
- 2221819
- 3013727803
- 3017233611
- 3014680735
- 3016854601
- 3007695959
- 3003647374
- 3033527283
- 1416980
- 1224842
- 3014134519
- 3015531959
- 3008386005
- 3014574557
- 3006110251
- 3010760216
- 3011274144
- 2134812
- 3005403518
- 3010280625
- 3010457937
- 1018470
- 3024673
- 3008921662
- 3011648943
- 3008595936
- 3003600763
- 3006597338
- 3010398867
- 9617592
- 9616515
- 9613994
- 3016096098
- 3011200896
- 9610595
- 3006330030
- 3012104670
- 3014555455
- 3006161756
- 3042254626
- 3037874486
- 3023245
- 3017884667
- 3009077524
- 3008321254
- 3006265099
- 9612283
- 3031158
- 3007738736
- 3017487805
- 3014432311
- 3007603826
- 3008223664
- 3009499478
- 3025429169
- 3012761544
- 2531475
- 8041160
- 1048735
- 1225687
- 1417592
- 3014755924
- 1221485
- 3009293490
- 3043226252
- 2134265
- 3014769442
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |