510(k) K925869
- Device
- SHEATHES, STERILE SHEATHES
- Applicant
- MAYER LABORATORIES
- 510(k) number
- K925869
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-01-06
- Date received
- 1992-11-19
- 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
- DAVID P MAYER
- Address
- 231 Fallon St. Oakland CA US 94607 94607
FDA Registration Numbers#
- 3032109181
- 9680794
- 3012316249
- 3032807464
- 3018781093
- 3009436116
- 9617277
- 3027788423
- 3003995932
- 3017487805
- 3010400367
- 3006161756
- 3015525240
- 3016253057
- 3019784575
- 3002183074
- 3010952312
- 9616774
- 3043226252
- 3009565060
- 3013595964
- 1220477
- 1000589001
- 3024673
- 3002807715
- 3009293490
- 3007994837
- 2133810
- 3015972810
- 3015276088
- 1450662
- 3014555455
- 3006850123
- 3005877899
- 3008321254
- 1055823
- 3014134519
- 2030624
- 3002315840
- 3006979678
- 9680269
- 3016854601
- 3009077524
- 3013436538
- 3013557562
- 3013844297
- 3011416394
- 3001763079
- 3007695959
- 3025429169
- 3004574050
- 3002808148
- 3010827261
- 3003832357
- 3013515803
- 1061927
- 3039935725
- 3003774756
- 3010305275
- 3004035727
- 3014432311
- 3004485675
- 1720929
- 3009482034
- 3040391009
- 2434141
- 3010398867
- 1018233
- 3030733800
- 3003647374
- 3012428212
- 3035373446
- 9710388
- 3013462478
- 9610595
- 3006597338
- 3011137372
- 3012975098
- 3006330030
- 3008595936
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 |
Legacy Summary#
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FDA Review#
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