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#
- 3008515880
- 3026405201
- 3017955833
- 1319639
- 3006680097
- 3006597338
- 1826555
- 3010381606
- 3010390468
- 3004009431
- 3015276088
- 3006110251
- 3016678045
- 3031259044
- 3031397684
- 3033527241
- 3017233611
- 3042172882
- 3003995932
- 9680794
- 3022472
- 3016436764
- 3019784575
- 3012428212
- 8030607
- 3038718997
- 3005636544
- 9615439
- 3015136743
- 3014574557
- 1000601180
- 3002807715
- 2031962
- 3011106828
- 2950776
- 9710602
- 9614698
- 3003782610
- 9611680
- 2532090
- 3008950127
- 9614641
- 1055823
- 3009565060
- 3016493665
- 3031851875
- 3006850123
- 2183319
- 3007994837
- 9680269
- 1720929
- 3012494290
- 3009436116
- 2030624
- 3003971136
- 3013557562
- 1047843
- 3037874486
- 3009212453
- 3009156722
- 3010457937
- 3010432890
- 3017884667
- 3003681187
- 3004752776
- 3003832357
- 2134265
- 1650907
- 3017406171
- 1226587
- 3005406110
- 2020394
- 3011692238
- 2124215
- 3017894900
- 3021226419
- 3007544634
- 2221819
- 3031569584
- 3010060157
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITX#
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|---|---|---|---|
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| 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 |