Latex Ultrasonic Probe Cover
FDA 510(k) K022156 · Pleasure Latex Products Sdn. Bhd.
510(k) numberK022156
Submission
- Device name
- Latex Ultrasonic Probe Cover
- Applicant
- Pleasure Latex Products Sdn. Bhd.
Jeram, Selangor Darul Ehsan, MY - Received
- July 2, 2002
- Decision date
- September 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code ITX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional | Olympus Medical Systems Corporation | 09/18/2025SE |
| K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional | Olympus Medical Systems Corporation | 07/11/2025SE |
| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K023333 | Multiple, Male Latex Condom [52MM or 56MM Nominal Width with Smooth or Dotted or Ribbed…HIS · Abbreviated | 06/23/2003SE |
| K021875 | Male Latex Condom with Dotted/Ribbed Surface and Counour-Walled Shape (3 in 1 Ultimate…HIS · Abbreviated | 09/05/2002SE |
| K020272 | Male Latex Condom with Ribbed SurfaceHIS · Abbreviated | 04/26/2002SE |
| K002571 | Mulitple Male Latx CondomHIS · Abbreviated | 11/16/2000SE |
| K001377 | Spermicidal Lubricated Male Latex CondomLTZ · Abbreviated | 06/08/2000SE |
| K001221 | Male Latex Comdom with Dotted SurfaceHIS · Abbreviated | 05/19/2000SE |
| K994312 | Male Latex Condom 56MMHIS · Abbreviated | 03/21/2000SE |
| K994311 | Male Latex Condom with Vanilla FlavorHIS · Abbreviated | 03/21/2000SE |
| K982380 | SureHIS · Traditional | 02/26/1999SE |
Questions and answers
When was Latex Ultrasonic Probe Cover cleared by the FDA?
Latex Ultrasonic Probe Cover (K022156) received a 510(k) decision of Substantially Equivalent on September 11, 2003, 436 days after the submission was received.
What is the product code of K022156?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.