General Purpose Atl Needle Guide Kit
FDA 510(k) K973958 · Protek Medical Products, Inc.
510(k) numberK973958
Submission
- Device name
- General Purpose Atl Needle Guide Kit
- Applicant
- Protek Medical Products, Inc.
Iowa City, IA, US - Received
- October 16, 1997
- Decision date
- January 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
|---|---|---|
| K973622 | Transducer PositionerITX · Traditional | 11/26/1997SE |
| K970893 | Ultrasound Transducer DrapeFYA · Traditional | 10/20/1997SE |
| K970889 | Ultrasound Transducer DrapeKKX · Traditional | 10/20/1997SE |
| K973362 | Needle Guide/GridITX · Traditional | 10/01/1997SE |
| K970885 | Ultrasound Systems DrapeMMP · Traditional | 09/22/1997SE |
| K970891 | Drape, Surgical-LatexKKX · Traditional | 08/22/1997SE |
| K971722 | Trans Vaginal Needle GuideITX · Traditional | 07/10/1997SE |
| K971115 | GE Medical-Needle Guide for SV, TR Andatf, Acuson-Needle GuideITX · Traditional | 06/13/1997SE |
Questions and answers
When was General Purpose Atl Needle Guide Kit cleared by the FDA?
General Purpose Atl Needle Guide Kit (K973958) received a 510(k) decision of Substantially Equivalent on January 22, 1998, 98 days after the submission was received.
What is the product code of K973958?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.